FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2140303
·
Received June 15, 2011
Report
- Report Number
- 3008642652-2011-00059
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- May 15, 2011
- Report Date
- June 15, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY WON'T HOLD CHARGE) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY OUTPUT VOLTAGE WAS MEASURED AT 6 VOLTS. THE CAUSE FOR THE LOW OUTPUT VOLTAGE CANNOT BE POSITIVELY DETERMINED BUT WAS LIKELY THE RESULT OF DEFECTIVE CELLS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PATIENT RECEIVED A REPLACEMENT BATTERY PACK.
Description of Event or Problem · 1
THE WIFE OF AN (B)(6) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS BATTERY PRODUCES A "BATTERY PROBLEM" MESSAGE WHEN PLACED ON 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 | 43 YR |