FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 5260682
·
Received December 2, 2015
Report
- Report Number
- 3008642652-2015-07763
- Event Type
- Malfunction
- Date Received
- December 2, 2015
- Date of Event
- November 14, 2015
- Report Date
- November 30, 2015
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION OF BATTERY SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER ON MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BATTERY WAS UNABLE TO POWER ON A MONITOR OR CHARGE. UPON EVALUATION, ONE OF THE BATTERY TRI-CELLS WAS DEPLETED. THE ROOT CAUSE FOR THE DEPLETED CELL COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.
Description of Event or Problem · 1
A US DISTRIBUTOR RETURNED BATTERY SN (B)(4) AND REPORTED THAT IT WAS UNABLE TO POWER ON HER MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 792843 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |