FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 25151180
·
Received May 12, 2026
Report
- Report Number
- 3008642652-2026-04621
- Event Type
- Malfunction
- Date Received
- May 12, 2026
- Date of Event
- May 11, 2026
- Report Date
- May 12, 2026
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005135
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION OF ELECTRODE BELT HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL ECGS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT DID NOT PASS AN ECG FALL-OFF TEST. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A BROKEN WIRE IN THE CABLE NEAR THE JST CONNECTOR. THE ROOT CAUSE FOR THE BROKEN WIRE COULD NOT BE POSITIVELY IDENTIFIED. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED BELT.
Description of Event or Problem · 0
A US DISTRIBUTOR REPORTED THAT AN ELECTRODE BELT HAD NON-FUNCTIONAL ECGS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58178 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | LIFEVEST WCD 4000 SYSTEM | 00855778005135 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |