FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2240933
·
Received August 9, 2011
Report
- Report Number
- 3008642652-2011-00397
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- April 3, 2011
- Report Date
- August 8, 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 WON'T CHARGE IN CHARGER) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY WOULD NOT CHARGE IN THE BATTERY CHARGER NOR POWER UP ON A MONITOR. LIQUID CONTAMINATION WAS DISCOVERED IN THE BATTERY PACK. THE ROOT CAUSE OF THE LIQUID CONTAMINATION CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY A RESULT OF LIQUID INGRESS. 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) MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT ONE OF HIS BATTERIES WOULD NOT CHARGE WHEN PLACED IN THE BATTERY 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 | 72 YR |