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

Model Number WCD 4000

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Syncope (1610); Death (1802)

Event Date 03/01/2020

Event Type  Death  

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.  the reported problem (patient death) was confirmed.  during the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the audio messaging and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.  there is no indication of a product malfunction.Electrode belt sn (b)(4) has not been recovered from the field.Device evaluation included review of downloaded software flag files on the day of the event.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.Device manufacturer date: monitor: 05/09/2019, electrode belt: 03/05/2019.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020, while wearing the lifevest.The patient's wife, sister, and brother in law were with the patient prior to passing.It was reported that the passing was cardiac related.It was reported that paramedics may have unplugged the lifevest.It was reported that the patient was not feeling well, 911 was called and the patient passed out.It was reported that the paramedics attempted resuscitation efforts.It was also reported that the patient experienced an appropriate treatment event consisting of 2 shocks.At 13:13:34 on (b)(6) 2020 the patient received an appropriate treatment.The patient's rhythm at the time of the treatment was ventricular tachycardia (vt) at 180 bpm and the post shock rhythm was sinus bradycardia at 35 bpm with motion artifact.At 13:18:25, the patient received a second appropriate treatment.The patient's rhythm at the time of the treatment was fine vf with possible cpr/motion artifact and the post shock rhythm was a sinus tachycardia with motion artifact.The patient's arrhythmia was successfully converted to a slower rhythm as a result of the treatment event.The patient's rhythm was ventricular fibrillation (vf) with cpr/motion artifact at 13:19:26.The patient received a non-lifevest defibrillation at 13:22:05.Cpr/motion artifact prevented the lifevest from treating the patient from 13:19:26 to 13:28:11.The patient was in asystole with cpr/motion artifact at the time of the electrode belt disconnection at 13:33:42 on (b)(6) 2020.The response buttons not were pressed during the event.The patient passed on (b)(6) 2020 at approximately 1:40pm.

Manufacturer Narrative

Device evaluation of monitor sn (b)(4) has been completed.  the reported problem (patient death) was confirmed.  during the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the monitor, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the audio messaging and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.  there is no indication of a product malfunction.Electrode belt sn (b)(4) has not been recovered from the field.Device evaluation included review of downloaded software flag files on the day of the event.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.Device manufacturer date monitor: 05/09/2019.Electrode belt: 03/05/2019.

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2020, while wearing the lifevest.The patient's wife, sister, and brother in law were with the patient prior to passing.It was reported that the passing was cardiac related.It was reported that paramedics may have unplugged the lifevest.It was reported that the patient was not feeling well, 911 was called and the patient passed out.It was reported that the paramedics attempted resuscitation efforts.It was also reported that the patient experienced an appropriate treatment event consisting of 2 shocks.At 13:13:34 on (b)(6) 2020 the patient received an appropriate treatment.The patient's rhythm at the time of the treatment was ventricular tachycardia (vt) at 180 bpm and the post shock rhythm was sinus bradycardia at 35 bpm with motion artifact.At 13:18:25, the patient received a second appropriate treatment.The patient's rhythm at the time of the treatment was fine vf with possible cpr/motion artifact and the post shock rhythm was a sinus tachycardia with motion artifact.The patient's arrhythmia was successfully converted to a slower rhythm as a result of the treatment event.The patient's rhythm was ventricular fibrillation (vf) with cpr/motion artifact at 13:19:26.The patient received a non-lifevest defibrillation at 13:22:05.Cpr/motion artifact prevented the lifevest from treating the patient from 13:19:26 to 13:28:11.The patient was in asystole with cpr/motion artifact at the time of the electrode belt disconnection at 13:33:42 on (b)(6) 2020.The response buttons not were pressed during the event.The patient passed on (b)(6) 2020 at approximately 1:40pm.

• 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: rachel mahoney ; 121 gamma drive; pittsburgh, pa ; 9683333
• MDR Report Key: 9991324
• MDR Text Key: 191483384
• Report Number: 3008642652-2020-03554
• 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,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2019
• 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): Death
• Patient Age: 67 YR