FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 17434675
·
Received August 1, 2023
Report
- Report Number
- 3008642652-2023-07517
- Event Type
- Malfunction
- Date Received
- August 1, 2023
- Date of Event
- June 9, 2023
- Report Date
- August 1, 2023
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
DEVICE EVALUATION OF ELECTRODE BELT SN (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 204) WAS ISOLATED TO THE CAN L, CAN H, AND DRVN -GRD WIRES IN THE TRUNK CABLE ALL MEASURING OPEN. THE ROOT CAUSE FOR THE OPEN WIRES WAS EXCESSIVE FORCE. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED BELT.
Description of Event or Problem · 0
A US DISTRIBUTOR REPORTED THAT A PATIENT'S ELECTRODE BELT WAS DISPLAYING A SERVICE CODE 204.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2343032 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | LIFEVEST WCD 4000 SYSTEM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |