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

Model Number LIFEVEST WCD 4000 SYSTEM

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

Patient Problems Bradycardia (1751); Tachycardia (2095); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Asystole (4442)

Event Date 09/13/2022

Event Type  Death  

Event Description

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2022 while reportedly wearing the lifevest.The patient received seven appropriate treatments, three which converted the arrhythmia to a slower rhythm and four which resulted in post shock asystole, and two inappropriate treatments.  the device was started up at 08:14:35 on (b)(6) 2022.At 09:59:40, an arrhythmia was detected.Ecg shows vf with motion artifact.At 10:00:17, the patient received the first appropriate treatment.The rhythm at the time of treatment was vf with motion artifact.The post shock rhythm was asystole for 15 seconds followed by a sinus beat degrading to vf.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.At 10:00:47, the patient received the second appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia @ 40 bpm.At 10:01:19, the patient received the third appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was asystole with intermittent cardiac activity and motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.At 10:01:54, the patient received the first 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 motion artifact.The post shock rhythm was asystole with intermittent cardiac activity and motion artifact transitioning to sinus bradycardia/rhythm from 30-60 bpm with pvcs.At 10:04:47, an arrhythmia was detected.Ecg shows sinus rhythm @ 90 bpm degrading to vf.At 10:05:21, the patient received the fourth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was asystole with intermittent cardiac activity and motion artifact.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.At 10:06:22, 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 motion artifact.The post shock rhythm was sinus bradycardia @ 50 bpm.At 10:06:56, the patient received the fifth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus rhythm @ 70 bpm.At 10:07:28, the patient received the sixth appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus tachycardia @ 100 bpm degrading to vf with motion artifact.At 10:08:00, the patient received the seventh appropriate treatment.The rhythm at the time of treatment was vf with motion artifact and electrode lead falloff.The post shock rhythm was asystole with intermittent cardiac activity, motion artifact and electrode lead falloff for 40 seconds before transitioning to sinus bradycardia from 20-50 bpm with pvcs.The rhythm then degrades back to vf/fine vf.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The electrode belt was disconnected at 15:14:45 on (b)(6) 2022.

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: 15465001
• MDR Text Key: 300386983
• Report Number: 3008642652-2022-23733
• 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: 09/21/2022

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: LIFEVEST WCD 4000 SYSTEM
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 09/22/2022
• 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