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); Heart Block (4444)

Event Date 06/15/2022

Event Type  Death  

Manufacturer Narrative

Device evaluation of the monitor and electrode belt has been completed.The evaluation included review of downloaded software flag files on the day of the event and incoming functional testing.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

A us distributor contacted zoll to report that a patient passed away on (b)(6) 2022 while reportedly wearing the lifevest.The patient received three appropriate shocks.Two converted the arrhythmias to a slower rhythm and one resulted in a post-shock asystole.The patient also received two inappropriate shocks.  the device was started up at 21:43:09 on (b)(6) 2022.At 02:22:04 on (b)(6) 2022, an arrhythmia was detected.Ecg shows sinus rhythm @ 90 bpm transitioning to vt @ 220 bpm.At 09:09:33, the patient received the first appropriate treatment.The rhythm at the time of treatment was vt @ 210 bpm.The post shock rhythm was sinus bradycardia @ 30 bpm with pvcs and motion artifact.At 02:23:21, the patient received the first inappropriate treatment.Nsvt and double counting contributed to the false detection.The rhythm at the time of treatment was sinus bradycardia @ 30 bpm with pvcs/nsvt and motion artifact.The post shock rhythm was sinus bradycardia @ 40 bpm with pvcs and motion artifact.At 02:27:14, an arrhythmia was detected.Ecg shows sinus rhythm @ 70 bpm with nsvt/bigeminy/pvcs and hb.At 02:27:49, the patient received the second inappropriate treatment.Nsvt and double counting contributed to the false detection.The rhythm at the time of treatment was sinus rhythm @ 90 bpm with nsvt/bigeminy/pvcs and hb.The post shock rhythm was sinus rhythm @ 90 bpm with nsvt/bigeminy/pvcs and hb.At 02:28:53, an arrhythmia was detected.Ecg shows vt @ 270 bpm.At 09:09:33, the patient received the second appropriate treatment.The rhythm at the time of treatment was vt @ 260 bpm.The post shock rhythm was sinus bradycardia @ 30 bpm with pvcs and hb.At 05:19:57, an arrhythmia was detected.Ecg shows vf.The electrode belt was disconnected at 05:20:54 on (b)(6) 2022.At 05:21:23, the patient received the third appropriate treatment.The rhythm at the time of treatment was vf with cpr/motion artifact.The post shock rhythm was asystole with motion artifact and electrode lead falloff.Post-shock asystole is a known and potentially adverse outcome of defibrillation therapy.The patient passed away 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: 15140419
• MDR Text Key: 297001169
• Report Number: 3008642652-2022-21575
• 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: 08/01/2022

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: 07/07/2022
• Initial Date FDA Received: 08/01/2022
• 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