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

Model Number WCD 4000

Device Problem Signal Artifact/Noise (1036)

Patient Problems Atrial Fibrillation (1729); Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130); Asystole (4442)

Event Date 01/17/2022

Event Type  Death  

Manufacturer Narrative

The electrode belt and monitor have 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 in the hospital while wearing the lifevest on (b)(6) 2022.Review of the download data, indicates the patient received 11 appropriate shocks during vf.At 00:10:49, the patient's rhythm was af with rvr at 160 bpm transitioning to vf with motion artifact.Motion artifact prevented the lifevest from treating the patient.At 00:12:13, the patient received the first appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus rhythm at 70 bpm with pvcs.At 00:13:47, the patient received the second appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus tachycardia at 100 bpm with pvcs and pacs degrading back to vf.At 00:15:03, the patient received the third appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus rhythm at 90 bpm with motion artifact and nsvt.At 00:16:31, the patient received the fourth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus bradycardia at 50 bpm with pvcs and nsvt degrading to vf with motion artifact.At 00:18:09, the patient received the fifth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was asystole with intermittent cardiac activity.At 00:20:22, the patient received the sixth appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus rhythm at 80 bpm with pvcs and nsvt.At 00:21:53, the patient received the seventh appropriate treatment.The patient's rhythm at the time of the treatment event was vf with motion artifact.The patient's post-shock rhythm was sinus rhythm at 90 bpm with pvcs degrading to vf.At 00:22:38, the patient received the eighth appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was af with rvr at 200 bpm with pvcs degrading to vf.At 00:23:11, the patient received the ninth appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was af at 140 bpm with pvcs and nsvt degrading to vf.At 00:23:57, the patient received the tenth appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was nsvt transitioning to vt at 230 bpm.At 00:24:18, the patient received the eleventh appropriate treatment.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was af with rvr at 170 bpm with pvcs and nsvt degrading to vf.The patient passed away on (b)(6) 2022 at approximately 12:30 am.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: 13538123
• MDR Text Key: 285663228
• Report Number: 3008642652-2022-01636
• 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: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2022
• 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
• Date Manufacturer Received: 01/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2015
• 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