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

Model Number WCD 4000

Device Problems Signal Artifact/Noise (1036); Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 04/05/2022

Event Type  Death  

Manufacturer Narrative

The monitor has been returned and the evaluation is underway.The device flag data from the last download does not indicate any device malfunction.The electrode has not been recovered.The device flag data from the last download does not indicate any device malfunction.

Event Description

A us distributor contacted zoll to report that a patient passed away while wearing the lifevest on (b)(6) 2022.Review of the download data, indicates the patient received three appropriate treatments during vf and one inappropriate treatment in response to oversensing of cardiac activity.At 00:56:21, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was sinus bradycardia at 40 bpm.At 00:59:51, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was sinus bradycardia at 30 bpm with motion artifact.At 01:11:45, the patient received the third appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was asystole with intermittent cardiac activity.At 01:12:16, the patient received the inappropriate treatment during asystole in response to oversensing of cardiac activity.The patient's post-shock rhythm was af at 140 bpm degrading to asystole with intermittent cardiac activity.From 01:12:51 to 12:05:57, the patient was intermittently seen in asystole.Device was shutdown at 12:05:57.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238 3495
• Manufacturer Contact: steven kyle ; 121 gamma drive; pittsburgh, PA 15238-3495 ; 4129683333
• MDR Report Key: 15199049
• MDR Text Key: 297606628
• Report Number: 3008642652-2022-05656
• 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: 08/10/2022

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: 08/10/2022
• Initial Date FDA Received: 08/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/29/2020
• 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