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

Model Number LIFEVEST WCD 4000 SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bradycardia (1751)

Event Date 07/16/2022

Event Type  malfunction  

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 a nursing home while wearing the lifevest on (b)(6) 2022.Per clinical review of the continuous ecg recording, the device was started up at 09:24:35 on (b)(6) 2022.At 18:54:38, the patient received a non-lifevest defibrillation.Rhythm at time of defibrillation was sinus bradycardia at 40 bpm with hb.Post shock rhythm was sinus bradycardia at 40 bpm with hb.Vt/vf was seen from approximately 18:56:45 to 18:59:30.Cpr/motion artifact and electrode lead fall off obscured the patient's rhythm and prevented the lifevest from treating the patient.At 18:59:39, the patient received a second non-lifevest defibrillation.Rhythm at time of treatment was vf with motion artifact and electrode lead fall off.Post shock rhythm was asystole with motion artifact and electrode lead fall off.Cpr/motion artifact and electrode lead fall off obscured the patient's rhythm and prevented the lifevest from treating the patient.The patient was last seen in sinus bradycardia at 30 bpm with hb and cpr/electrode lead fall off from approximately 19:01:45 until the electrode belt was disconnected at 19:09:15 on (b)(6) 2022.

Manufacturer Narrative

Device evaluation of electrode belt has been completed.The reported problem (failed incoming testing) has been confirmed.Upon investigation the electrode belt failed an ecg fall-off test.The cause for the failure was a migrating pulse wire in ecg c shorting +5v and -5v which led to an ecg d falloff failure.The root cause for the migrated wire was not positively identified.There is no indication the short in the ecg caused or contributed to the patient death as the system was able to detect vt/vf rhythms on the date of event.Device evaluation of the monitor has been completed.During the incoming functional testing, a 1hz simulated normal sinus rhythm signal was applied to the ecg electrodes, followed by a 5hz simulated treatable arrhythmia signal which verified proper performance of the detection algorithm.During the transition to the 5hz signal, the device was confirmed to properly enter into a treatment sequence which includes a verification of the tactile vibration alarm, audio messaging, and siren alarms, as well as a test of the pulse delivery circuitry.The pulse delivery circuitry test verified proper charging of the high voltage capacitors and proper delivery of five full energy 150j biphasic pulses.The functional testing confirmed proper response button functionality, ecg acquisition, detection algorithm performance, and pulse delivery functionality.There is no indication of a product malfunction.

Event Description

The electrode belt was returned for investigation into a patient death and failed incoming functional testing.************************************************************************************************************************** a us distributor contacted zoll to report that a patient passed away in a nursing home while wearing the lifevest on (b)(6) 2022.Per clinical review of the continuous ecg recording, the device was started up at 09:24:35 on (b)(6) 2022.At 18:54:38, the patient received a non-lifevest defibrillation.Rhythm at time of defibrillation was sinus bradycardia at 40 bpm with hb.Post shock rhythm was sinus bradycardia at 40 bpm with hb.Vt/vf was seen from approximately 18:56:45 to 18:59:30.Cpr/motion artifact and electrode lead fall off obscured the patient's rhythm and prevented the lifevest from treating the patient.At 18:59:39, the patient received a second non-lifevest defibrillation.Rhythm at time of treatment was vf with motion artifact and electrode lead fall off.Post shock rhythm was asystole with motion artifact and electrode lead fall off.Cpr/motion artifact and electrode lead fall off obscured the patient's rhythm and prevented the lifevest from treating the patient.The patient was last seen in sinus bradycardia at 30 bpm with hb and cpr/electrode lead fall off from approximately 19:01:45 until the electrode belt was disconnected at 19:09:15 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: 15174502
• MDR Text Key: 297341410
• Report Number: 3008642652-2022-21816
• 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,Followup
• Report Date: 08/22/2022

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?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: LIFEVEST WCD 4000 SYSTEM
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/04/2022
• Initial Date FDA Received: 08/05/2022
• Supplement Dates Manufacturer Received: 08/22/2022
• Supplement Dates FDA Received: 08/24/2022
• 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