FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2011926
·
Received February 14, 2011
Report
- Report Number
- 3002158293-2011-00172
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- October 25, 2010
- Report Date
- February 10, 2011
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY/CHARGER FAULT) HAS BEEN CONFIRMED. UPON EVALUATION, THE WHITE WIRE WAS DETACHED FROM THE BATTERY CELL. THE CAUSE FOR THE DETACHED WIRE CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.
Description of Event or Problem · 1
A (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HER BATTERY CHARGER FLASHES RED WHEN A PARTICULAR BATTERY IS INSERTED INTO THE CHARGER. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR |