MAUDE Adverse Event Report: ZOLL MANUFACTURING CORPORATION LIFEVEST WCD 4000 SYSTEM; WEARABLE CARDIOVERTER DEFIBRILLATOR

Model Number WCD 4000

Device Problem Defibrillation/Stimulation Problem (1573)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/26/2020

Event Type  Injury  

Manufacturer Narrative

Explanation: there was no death associated with the defibrillation event.Device evaluation summary: electrode belt sn (b)(4) was returned and evaluated at the distributor, in accordance with procedures recommended by zoll manufacturing corporation.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.The review of the software flags consisted of an analysis of the downloaded data to identify any fault flags or unusual patterns of software flags.The software flag files did not suggest a device malfunction that would contribute to the inappropriate treatment.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.The pulse delivery circuitry test verified proper delivery of a full energy 150j biphasic pulse.The functional testing confirmed proper ecg acquisition and pulse delivery functionality.Monitor sn (b)(4) was returned to the distributor for evaluation.The evaluation of the monitor confirmed the service code 104/dl code 203.The sd card was defective.The distributor evaluation included downloaded data review as well as incoming functional testing of the device's ecg acquisition and pulse delivery circuitry, as recommended by zoll manufacturing.The monitor passed essential performance testing.The root cause of the defective sd card could not be positively identified.A review of the patient's downloaded flag file confirmed that the device declared a treatable arrhythmia and subsequently delivered one treatment defibrillation.The associated ecg strip of the treatment event could not be recovered due to an sd card fault.As such, the exact rhythm at the time of the event cannot be confirmed.Since we cannot definitively confirm if the treatment was appropriate or inappropriate, we are reporting the event out of an abundance of caution.The sd card fault did not preclude the device's ability to detect an arrhythmia and deliver a treatment defibrillation.Inappropriate defibrillations are an anticipated risk associated with the use of the lifevest.Patients are instructed through alarms, voice messages, ifu, and training to press the response buttons to prevent an inappropriate defibrillation.The current commercial inappropriate defibrillation rate is consistent with the observed rate during the pivotal clinical trial (b)(4) (0.69%per patient-month with 90% confidence).A summary of the safety and effectiveness data (ssed), including the inappropriate defibrillation safety objective supporting fda's approval of the lifevest, can be found at http://www.Accessdata.Fda.Gov/cdrh_docs/pdf/p010030b.Pdf.The lifevest detection algorithm complies with iec 60601-2-4 performance requirements for sensitivity and specificity.(b)(4).

Event Description

A us distributor contacted zoll to report that a patient experienced a defibrillation event consisting of one shock.No details surrounding the event were reported.The patient's ecg rhythm at the time of the treatment is unknown.The response buttons were not pressed during the event.The patient went to the hospital and continued wearing the lifevest.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh, pa
• Manufacturer Contact: brooke arnold ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 9802640
• MDR Text Key: 182981563
• Report Number: 3008642652-2020-02005
• Device Sequence Number: 1
• Product Code: MVK
• UDI-Device Identifier: 00855778005005
• UDI-Public: 00855778005005
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P010030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: WCD 4000
• Device Catalogue Number: 10A0988
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 03/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 42 YR