FDA Adverse Event
Death
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 24556056
·
Received March 10, 2026
Report
- Report Number
- 3008642652-2026-02352
- Event Type
- Death
- Date Received
- March 10, 2026
- Date of Event
- February 8, 2026
- Report Date
- March 2, 2026
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005005
- PMA / PMN Number
- P010030
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
THE ELECTRODE BELT AND MONITOR HAVE NOT BEEN RECOVERED. THE DEVICE FLAG DATA FROM THE LAST DOWNLOAD DOES NOT INDICATE ANY DEVICE MALFUNCTION.
Description of Event or Problem · 0
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT A PATIENT PASSED AWAY ON (B)(6) 2026 WHILE REPORTEDLY WEARING THE LIFEVEST. THE DEVICE WAS STARTED UP AT 10:00:20 ON (B)(6) 2026. AT 14:48:39, AN ARRHYTHMIA WAS DETECTED. ECG SHOWS VT FROM 210-270 BPM WITH CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF. THE DEVICE PROPERLY DETECTED VT. CPR/MOTION ARTIFACT AND ELECTRODE LEAD FALL OFF, PREVENTED THE LIFEVEST FROM TREATING THE PATIENT. THE DEVICE WAS SHUT DOWN AT 15:38:04 ON (B)(6) 2026.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 504309 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | LIFEVEST WCD 4000 SYSTEM | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Death |