FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 14522623
·
Received May 27, 2022
Report
- Report Number
- 3008642652-2022-05299
- Event Type
- Malfunction
- Date Received
- May 27, 2022
- Date of Event
- May 2, 2022
- Report Date
- May 26, 2022
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005005
- 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 MONITOR HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO A DEFECTIVE U104 PXA PROCESSOR ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE DEFECTIVE U104 PXA PROCESSOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DAMAGED MONITOR.
Description of Event or Problem · 0
A US DISTRIBUTOR REPORTED THAT A MONITOR WILL NOT POWER UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320648 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |