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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Inappropriate/Inadequate Shock/Stimulation (1574); Device Sensing Problem (2917); Device Fell (4014)

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

Event Date 01/02/2023

Event Type  Death  

Manufacturer Narrative

The electrode belt and monitor have been returned and the evaluation is underway.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 on (b)(6) 2023 while reportedly wearing the lifevest.The patient received six appropriate treatment, five of which converted the arrhythmias to a slower rhythm and one which did not convert the arrhythmia.The patient also received an inappropriate treatment and a non-lifevest defibrillation.The device was started up at 13:23:13 on (b)(6) 2023.At 01:04:53 on (b)(6) 2023, an arrhythmia was detected.Ecg shows sinus rhythm @ 60 bpm with pvc degrading to vf.At 01:05:54, the patient received the first appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 20 bpm with motion/tactile artifact, hb and pvcs.At 01:06:55, an arrhythmia was detected.Ecg shows vf with motion artifact.At 01:07:27, the patient received the second appropriate treatment.The rhythm at the time of treatment was vf with motion artifact.The post shock rhythm was sinus bradycardia @ 30 bpm with motion/tactile artifact, hb and pvcs degrading to vf.At 01:08:45, the patient received the third appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia from 15-30 bpm with motion/tactile artifact, hb and pvcs degrading to vf.At 01:09:19, the patient received the fourth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was vf.At 01:09:52, the patient received the fifth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 40 bpm with pvcs.At 01:10:23, the patient received the first inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The rhythm at the time of treatment was sinus rhythm @ 90 bpm with pvcs/nsvt.The post shock rhythm was vf.At 01:10:57, the patient received the sixth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 30 bpm with pvcs/nsvt degrading to vf with cpr/motion artifact.At, 01:29:58, the patient received the non-lifevest defibrillation.The rhythm at the time of the non-lifevest defibrillation was vf with cpr/motion artifact.Post shock rhythm was asystole with intermittent cardiac activity and cpr/motion artifact.At 01:34:58, an arrhythmia was detected.Ecg shows asystole with intermittent cardiac activity and cpr/motion artifact.At 01:35:57, the patient received the second inappropriate treatment.Oversensing of cardiac activity contributed to the false detection.The patient was in a non-life sustaining rhythm prior to the treatment.The rhythm at the time of treatment was asystole with intermittent cardiac activity and cpr/motion artifact.The post shock rhythm continued to be in asystole, which is a non-life sustaining rhythm, with motion artifact and electrode lead falloff.The electrode belt was disconnected at 1:36:22 on (b)(6) 2023.

• 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: 16273059
• MDR Text Key: 308492351
• Report Number: 3008642652-2023-00994
• 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: 01/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2023
• 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: 01/04/2023
• 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