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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problems Over-Sensing (1438); Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problems Bradycardia (1751); Ventricular Fibrillation (2130); Shock from Patient Lead(s) (3162); Asystole (4442); Heart Block (4444)

Event Date 09/08/2022

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 on an unknown date while reportedly wearing the lifevest.The patient received two appropriate treatments, one which converted the arrhythmia to a slower rhythm and one which resulted in post shock asystole and two inappropriate treatments.  the device was started up at 09:19:51 on (b)(6) 2022.At 15:34:23, an arrhythmia was detected.Ecg shows vf.At 15:35:13, the patient received the first appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was sinus bradycardia from 25-50 bpm with hb.At 15:56:36, an arrhythmia was detected.Ecg shows vf.At 15:57:28, the patient received the second appropriate treatment.The rhythm at the time of treatment was vf.The post shock rhythm was asystole with intermittent cardiac activity.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.At 15:58:20, the patient received the first inappropriate treatment.The patient was in a non-life sustaining rhythm prior to the treatment.Oversensing of cardiac activity contributed to the false detection.The rhythm at the time of treatment was asystole with intermittent cardiac activity.The post shock rhythm was asystole.At 15:58:47, the patient received the second inappropriate treatment.The patient was in a non-life sustaining rhythm prior to the treatment.Oversensing of cardiac activity contributed to the false detection.The rhythm at the time of treatment was asystole.The post shock rhythm was asystole with intermittent cardiac activity.The device was shut down at 1:04:44 on (b)(6) 2022.

• 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: 15464346
• MDR Text Key: 300381355
• Report Number: 3008642652-2022-23731
• 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: 09/17/2022
• 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