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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Signal Artifact/Noise (1036)

Patient Problems Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130); Asystole (4442); Heart Block (4444)

Event Date 06/21/2022

Event Type  Death  

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 3 appropriate shocks during vt/vf.At 15:49:59, the patient received the first appropriate treatment from the lifevest.The patient's rhythm at the time of the treatment event was vf.The patient's post-shock rhythm was asystole with unconducted p waves for 24 seconds transitioning to sinus bradycardia at 20 bpm with pvcs and hb.At 15:55:21, the patient received a non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with motion artifact.Post shock rhythm was vt at 160 bpm with motion artifact degrading to vf with motion artifact.The non-lifevest defibrillation occurred 29 seconds into the treatment sequence.Motion artfiact obscured the rhythm and prevented the lifevest from delivering a treatment.At 15:56:24, the patient received the second appropriate treatment from the lifevest.The patient's rhythm at the time of the treatment event was vf with cpr/motion artifact.The patient's post-shock rhythm was asystole with unconducted p waves for 32 seconds transitioning to sinus bradycardia at 20 bpm with pvcs.At 15:58:45, the patient received a second non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with cpr/motion artifact.Post shock rhythm was vt at 120 bpm with cpr/motion artifact.The non-lifevest defibrillation occurred 41 seconds into the treatment sequence.Cpr/motion artifact delayed the lifevest from treating the patient.At 15:59:08, the patient received the third appropriate treatment from the lifevest.The patient's rhythm at the time of the treatment event was vt at 120 bpm with cpr/motion artifact.The patient's post-shock rhythm was asystole with motion artifact.The patient's rhythm was asystole with motion artifact and electrode lead fall off from approximately 16:03:18 until the electrode belt was disconnected at 18:40:35.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.

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.

• Brand Name: LIFEVEST WCD 4000 SYSTEM
• Type of Device: WEARABLE CARDIOVERTER DEFIBRILLATOR
• Manufacturer (Section D): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA 15238
• Manufacturer (Section G): ZOLL MANUFACTURING CORPORATION; 121 gamma drive; pittsburgh PA
• Manufacturer Contact: zoll mfg corporation ; 121 gamma drive; pittsburgh, PA 15238
• MDR Report Key: 15183274
• MDR Text Key: 297461972
• Report Number: 3008642652-2022-21849
• Device Sequence Number: 1
• Product Code: MVK
• 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: 08/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Date Manufacturer Received: 08/08/2022
• 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