Equipment Failure

设备故障
  • 文章类型: Journal Article
    背景:虽然罕见,在介入手术期间可能发生导丝骨折。在大多数情况下,断裂的导丝段可以被移除。
    方法:我们报告了一例54岁的女性,在经皮肾造瘘术(PCN)进行经皮肾镜取石术以清除肾结石的过程中发生导丝骨折。
    方法:肾结石。
    方法:PCN和经皮肾镜取石术。
    结果:在这种情况下,其余节段无法切除,引起炎症和感染.然而,通过住院治疗,她的症状得到了改善。因此,她出院并随访了5年。
    结论:进行PCN以清除肾结石时,必须考虑导丝断裂的可能性。如果在处理导丝时感觉到阻力或刮擦,那么它应该被替换。
    BACKGROUND: Although rare, guidewire fractures can occur during interventional procedures. In most cases, the fractured guidewire segment can be removed.
    METHODS: We report the case of a 54-year-old woman who experienced a guidewire fracture during percutaneous nephrostomy (PCN) for percutaneous nephrolithotomy to remove renal stones.
    METHODS: Nephrolithiasis.
    METHODS: PCN and percutaneous nephrolithotomy.
    RESULTS: In this case, the remaining segment could not be removed and caused inflammation and infection. However, her symptoms improved with inpatient treatment. Therefore, she was discharged from the hospital and followed up for 5 years.
    CONCLUSIONS: When performing PCN to remove renal stones, the possibility of a guidewire fracture must be considered. If resistance or scraping is felt while handling the guidewire, then it should be replaced.
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    文章类型: English Abstract
    目的:通过锁相红外探伤方法测试了机械镍钛文件的抗疲劳性,为了及时检测仪器的磨损,为临床安全使用和及时废弃镍钛档案提供参考。
    方法:从Reciproc-Blue(RB)中选择20套机械镍钛文件,MTWO和S3,并制备了60°和90°弯曲的树脂模拟根管,分为6个亚组。使用后的疲劳值,记录各组文件断裂前的使用次数和25号文件的断裂长度,并与SPSS26.0软件包进行比较。
    结果:随着使用次数的增加,三种档案的疲劳值逐渐增加。在两种类型的弯曲根管中,与MTWO组和S3组相比,RB组骨折前使用次数显著增加(P<0.05)。90°弯曲根管中三种牙列的使用次数明显少于60°弯曲根管中相应组(P<0.05)。3种手法间骨折长度差异无统计学意义(P>0.05).
    结论:锁相红外探伤方法可用于镍钛文件的无损检测和疲劳程度的定量分析。
    OBJECTIVE: The fatigue resistance of mechanical nickel-titanium files was tested by phase-locked infrared flaw detection method, in order to timely detect instrument wear, providing reference for clinical safe use and timely abandonment of nickel-titanium files.
    METHODS: Twenty sets of mechanical nickel-titanium files were selected from Reciproc-Blue(RB), MTWO and S3 respectively, and resin simulated root canals with 60° and 90° bending were prepared, which were divided into 6 subgroups. The fatigue value after use, the number of uses before breaking and the length of fracture of file 25# of each group of files were recorded and compared with SPSS 26.0 software package.
    RESULTS: With the increase of the times of use, the fatigue value of the three kinds of files increased gradually. Among the two types of curved root canals, the number of uses before fracture in RB group was significantly increased compared with that in MTWO group and S3 group (P<0.05). The number of uses of the three kinds of files in the 90° curved root canal were significantly less than in the corresponding groups in the 60° curved root canal(P<0.05). There was no significant difference in the length of fracture among the three kinds of files(P>0.05).
    CONCLUSIONS: Phase-locked infrared flaw detection method can be used for non-destructive testing and quantitative analysis of the fatigue degree of nickel-titanium files.
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  • 文章类型: Journal Article
    目的:皮下植入式心律转复除颤器(S-ICD)已在预防心源性猝死中确立,与经静脉除颤器系统相比有一些优势,包括较低的引线故障发生率。尽管技术进步,S-ICD携带者可能患有严重的并发症,例如电池过早耗尽(PBD),这导致了近4万名患者的咨询。这项多中心研究评估了大量S-ICD患者中PBD的发生率。
    结果:回顾了2012年10月至2023年7月在欧洲和美国的9个中心植入S-ICD模型A209和A219的患者的数据。PBD的发生率和影响,定义为临床观察到的电池寿命突然下降,进行了分析,并与60个月内电池耗尽的定义的PBD进行了比较。前瞻性收集的临床数据从病历中获得,设备遥测,和制造商报告。该注册表列在ClinicalTrials.gov(NCT05713708)上。在分析的1112台S-ICD装置中,547(49.2%)配备了与PBD事件相关的潜在受影响的电容器,目前在食品和药物管理局的咨询。所有患者的中位随访时间为46[四分位距(IQR)24-63]个月。在159例(29.1%)中观察到临床怀疑的PBD,去除或更换发电机的中位时间为65个月(IQR55-72),表明与预期电池寿命有显著偏差。在91.7%的返回用于分析的设备中,制造商确认了PBD。未在未咨询的装置中观察到PBD病例。
    结论:这项独立于制造商的分析强调了在咨询下配备S-ICD模型的患者中PBD的显著发生率,本研究中PBD的比率与制造商目前估计的比率相对应。据我们所知,本研究提供了当代最大的同行评审研究队列,调查了S-ICD患者中PBD的实际发病率.这些发现强调了上市后注册在临床医生和制造商之间合作以优化S-ICD治疗的安全性和有效性的重要性。
    OBJECTIVE: Subcutaneous implantable cardioverter-defibrillators (S-ICDs) have become established in preventing sudden cardiac death, with some advantages over transvenous defibrillator systems, including a lower incidence of lead failures. Despite technological advancements, S-ICD carriers may suffer from significant complications, such as premature battery depletion (PBD), that led to an advisory for nearly 40 000 patients. This multicentre study evaluated the incidence of PBD in a large set of S-ICD patients.
    RESULTS: Data from patients implanted with S-ICD models A209 and A219 between October 2012 and July 2023 across nine centres in Europe and the USA were reviewed. Incidence and implications of PBD, defined as clinically observed sudden drop in battery longevity, were analysed and compared to PBD with the definition of battery depletion within 60 months. Prospectively collected clinical data were obtained retrospectively from medical records, device telemetry, and manufacturer reports. This registry is listed on ClinicalTrials.gov (NCT05713708). Of the 1112 S-ICD devices analysed, 547 (49.2%) were equipped with a potentially affected capacitor linked to PBD occurrence, currently under Food and Drug Administration advisory. The median follow-up time for all patients was 46 [inter-quartile range (IQR) 24-63] months. Clinically suspected PBD was observed in 159 (29.1%) of cases, with a median time to generator removal or replacement of 65 (IQR 55-72) months, indicative of significant deviations from expected battery lifespan. Manufacturer confirmation of PBD was made in 91.7% of devices returned for analysis. No cases of PBD were observed in devices that were not under advisory.
    CONCLUSIONS: This manufacturer-independent analysis highlights a notable incidence of PBD in patients equipped with S-ICD models under advisory, and the rate of PBD in this study corresponds to the rate currently estimated by the manufacturer. To the best of our knowledge, this provides the largest contemporary peer-reviewed study cohort investigating the actual incidence of PBD in S-ICD patients. These findings emphasize the importance of post-market registries in collaboration between clinicians and the manufacturer to optimize safety and efficacy in S-ICD treatment.
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  • 文章类型: Journal Article
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  • 文章类型: Letter
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  • 文章类型: Journal Article
    MAUDE数据库是了解与医疗设备和健康IT相关的故障和不良事件的宝贵公共资源。然而,其广泛的数据和复杂的结构带来了挑战。为了克服这一点,我们使用先进的大型语言模型GPT-4开发了自动分析管道。这条管道旨在有效地提取,归类,并以最少的人为注释可视化安全事件。在我们对MAUDE(2011-2021)的4459例结肠镜检查报告的分析中,这些事件被归类为可操作的,人为因素,和设备相关。Ishikawa图可视化了存储在矢量数据库中的子集,以便通过相似性搜索进行轻松检索和比较。这种创新方法简化了对重要安全见解的访问,减少人类注释者的工作量,并有望增强MAUDE数据库的实用性。
    The MAUDE database is a valuable public resource for understanding malfunctions and adverse events related to medical devices and health IT. However, its extensive data and complex structure pose challenges. To overcome this, we have developed an automated analytical pipeline using GPT-4, a cutting-edge large language model. This pipeline is intended to efficiently extract, categorize, and visualize safety events with minimal human annotation. In our analysis of 4,459 colonoscopy reports from MAUDE (2011-2021), the events were categorized into operational, human factor, and device-related. Ishikawa diagrams visualized a subset stored in a vector database for easy retrieval and comparison through a similarity search. This innovative approach streamlines access to vital safety insights, reducing the workload on human annotators, and holds promise to enhance the utility of the MAUDE database.
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  • 文章类型: Journal Article
    麻醉气体清除系统(AGSS)从麻醉机中去除废气。在AGSS中,安全功能防止过度的压力影响通风。尽管文献包含描述AGSS故障的报告,我们没有发现正压泄压阀(PPRV)故障的报告.我们遇到了2例因PPRV故障而导致的外部呼气末正压(PEEP)。两种情况都在术中延迟识别,但患者未出现术后并发症。这些案例凸显了每日清道夫系统预检的重要性,AGSS故障的潜在生理意义,以及预先计划的突发事件对机器故障的重要性。
    The anesthesia gas scavenging system (AGSS) removes waste gases from the anesthesia machine. Within the AGSS, safety features prevent excessive pressures from affecting ventilation. Although the literature contains reports describing failures of the AGSS, we found no reports of positive-pressure relief valve (PPRV) malfunctions. We encountered 2 cases of extrinsic positive end-expiratory pressure (PEEP) resulting from a malfunctioning PPRV. Both cases suffered delayed identification intraoperatively but patients did not experience postoperative complications. These cases highlight the importance of daily scavenger system prechecks, the potential physiologic implications of AGSS malfunctions, and the importance of preplanned contingencies for machine failure.
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  • 文章类型: Letter
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  • 文章类型: Case Reports
    背景:心脏植入式电子设备(CIED)并发症在临床实践中提出了重大挑战,尤其是患有多种合并症的老年患者。常见的不良事件包括感染,导线故障,和设备迁移。Twiddler综合征,一种罕见但严重的ED并发症,其特征是患者操作导致导线移位和设备故障,经常被低估。文献主要由病例报告和小系列组成,在预防和管理方面提供有限的指导。AsCIED对于管理心律失常和心力衰竭至关重要,理解和解决Twiddler综合征至关重要。本病例报告旨在通过详述Twiddler综合征的病例来为文献做出贡献,强调多学科方法对优化管理的重要性。
    方法:一名59岁男性在过去两天内出现植入式心脏复律除颤器(ICD)部位和胸骨区域周围的不适。他否认疼痛,呼吸困难,或者头晕.临床检查显示心律正常,无外周脉搏不足。超声显示左心室射血分数降低。心房导线不可见,电击线圈放错了地方。ICD询问显示由于两条导线中的感应伪影和出口阻塞而导致的不适当电击,没有检测到心律失常.X射线证实了铅移位和口袋中的明显缠结。患者被诊断为Twiddler综合征,并计划进行手术翻修。
    结论:扩张型心肌病(DCM),以左心室扩张和功能障碍为特征,占收缩性心力衰竭病例的很大比例。尽管在心力衰竭管理方面取得了进展,DCM患者仍然处于心源性猝死(SCD)的高风险,使ICD植入至关重要。然而,CIED放置有并发症的风险,包括Twiddler综合征.这种情况可能导致导线移位和设备故障,导致不适当的电击和潜在的患者伤害。在这种情况下,使用多学科方法成功进行了单次摘除和重新植入,强调综合管理策略对有效解决此类并发症的重要性。定期随访显示无不良事件,强调该程序的成功和使用先进的抗菌辅助预防感染的潜在好处。该病例强调了管理Twiddler综合征的意识和标准化方案的必要性,以改善日益增长的CIED接受者人群的患者预后。
    BACKGROUND: Cardiac implantable electronic device (CIED) complications present significant challenges in clinical practice, especially in elderly patients with multiple comorbidities. Common adverse events include infection, lead malfunction, and device migration. Twiddler\'s Syndrome, a rare but serious CIED complication characterised by patient manipulation causing lead displacement and device malfunction, is often underreported. The literature consists mainly of case reports and small series, providing limited guidance on prevention and management. As CIEDs are critical for managing cardiac arrhythmias and heart failure, understanding and addressing Twiddler\'s Syndrome is essential. This case report aims to contribute to the literature by detailing a case of Twiddler\'s Syndrome, emphasising the importance of a multidisciplinary approach for optimal management.
    METHODS: A 59-year-old male presented with discomfort around his implantable cardioverter defibrillator (ICD) site and the sternal area over the past two days. He denied pain, dyspnoea, or dizziness. Clinical examination revealed a normal heart rhythm and no peripheral pulse deficit. Ultrasound revealed a reduced left ventricular ejection fraction. The atrial lead was not visible, and the shock coil was misplaced. ICD interrogation showed inappropriate shocks due to sensing artifacts and exit block in both leads, with no arrhythmias detected. An X-ray confirmed lead dislodgement and significant entanglement in the pocket. The patient was diagnosed with Twiddler\'s Syndrome and scheduled for surgical revision.
    CONCLUSIONS: Dilated cardiomyopathy (DCM), characterised by left ventricular dilatation and dysfunction, accounts for a significant proportion of systolic heart failure cases. Despite advancements in heart failure management, DCM patients remain at high risk for sudden cardiac death (SCD), making ICD implantation crucial. However, CIED placement carries risks of complications, including Twiddler\'s Syndrome. This condition can lead to lead dislodgement and device malfunction, resulting in inappropriate shocks and potential patient harm. In this case, a single-session extraction and re-implantation were successfully performed using a multidisciplinary approach, emphasising the importance of comprehensive management strategies to address such complications effectively. Regular follow-up showed no adverse events, highlighting the procedure\'s success and the potential benefits of using advanced antimicrobial adjuncts to prevent infections. This case underscores the need for awareness and standardised protocols for managing Twiddler\'s Syndrome to improve patient outcomes in the growing population of CIED recipients.
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  • 文章类型: Journal Article
    根管治疗中使用的镍钛(NiTi)旋转文件由于复杂的弯曲几何形状和根管内遇到的操作条件而经历疲劳和剪切损伤。这可能会导致文件过早断裂,导致严重的并发症。全面了解不同因素如何导致文件损坏对于改善其功能寿命至关重要。本研究探讨了根管曲率半径的综合影响,文件运河曲率,通过集成的计算和实验方法,研究了NiTi牙髓组织的疲劳寿命和失效模式。进行了先进的有限元模拟,精确地复制了弯曲运河几何形状内文件的动态运动。提取临界应力/应变值并将其纳入经验疲劳模型以预测牙髓文件的功能寿命。在各种运河曲率和速度下在人造弯曲运河内旋转的文件的广泛实验提供了验证。增加根管曲率超过60°和更短的曲率半径低于5mm显著减少了牙髓的功能寿命。特别是在转速超过360转/分。基于应变振幅的Coffin-Manson疲劳模型与实验最接近。在较低的运河曲率下,剪应力主导了破坏,而在较高的运河曲率下,组合的剪切-疲劳载荷效应显着。这项结论性研究阐明了像运河曲率半径这样的运行参数,运河曲率,和转速协同影响NiTi文件的疲劳损伤过程。这些发现为优化这些因素提供了有价值的指导方针,显着延长牙髓的功能寿命并降低术中失败的风险。经过验证的计算方法为制造前的新文件设计的虚拟测试和功能寿命估计提供了强大的工具。
    Nickel-titanium (NiTi) rotary files used in root canal treatments experience fatigue and shear damage due to the complex curved geometries and operating conditions encountered within the root canal. This can lead to premature file fracture, causing severe complications. A comprehensive understanding of how different factors contribute to file damage is crucial for improving their functional life. This study investigates the combined effects of root canal curvature radius, file canal curvature, and rotational speed on the fatigue life and failure modes of NiTi endodontic files through an integrated computational and experimental approach. Advanced finite element simulations precisely replicating the dynamic motion of files inside curved canal geometries were conducted. Critical stress/strain values were extracted and incorporated into empirical fatigue models to predict the functional life of endodontic files. Extensive experiments with files rotated inside artificial curved canals at various canal curvatures and speeds provided validation. Increasing the canal curvature beyond 60∘ and shorter curvature radii below 5 mm dramatically reduced the functional life of the endodontic file, especially at rotational speeds over 360 rpm. The Coffin-Manson fatigue model based on strain amplitude showed the closest agreement with experiments. Shear stresses dominated damage at low canal curvatures, while the combined shear-fatigue loading effects were prominent at higher canal curvatures. This conclusive study elucidates how operational parameters like canal curvature radii, canal curvature, and rotational speed synergistically influence the fatigue damage processes in NiTi files. The findings offer valuable guidelines to optimize these factors, significantly extending the functional life of endodontic files and reducing the risk of intra-operative failures. The validated computational approach provides a powerful tool for virtual testing and estimation of the functional life of the new file designs before manufacturing.
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