FDA Adverse Event
Malfunction
Summary report: N
HWD 1000 SYSTEM
MDR report key: 16385056
·
Received February 16, 2023
Report
- Report Number
- 3008642652-2023-01348
- Event Type
- Malfunction
- Date Received
- February 16, 2023
- Date of Event
- February 15, 2023
- Report Date
- February 16, 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 BATTERY PACK HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) WAS CONFIRMED. AS RECEIVED, THE BATTERY WAS UNABLE TO POWER ON A MONITOR OR CHARGE. THE CAUSE FOR THE FAILURE WAS ISOLATED TO DISCHARGED CELLS. THE ROOT CAUSE OF THE DISCHARGED CELLS CANNOT BE POSITIVELY IDENTIFIED. THERE WAS NO ADVERSE EVENT THAT RESULTED FROM THE DAMAGED BATTERY.
Description of Event or Problem · 0
A US DISTRIBUTOR REPORTED THAT A BATTERY WOULD NOT POWER ON A MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 358759 | HWD 1000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | HWD 1000 SYSTEM |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |