FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1983740
·
Received February 4, 2011
Report
- Report Number
- 3002158293-2011-00122
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- December 24, 2010
- Report Date
- February 2, 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 POWER UP MONITOR) HAS BEEN CONFIRMED. UPON EVALUATION, THE BATTERY OUTPUT VOLTAGE WAS MEASURED AT 2.52V. THE CAUSE FOR THE LOW OUTPUT VOLTAGE CANNOT BE POSITIVELY IDENTIFIED. 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 NEITHER OF HER BATTERIES WILL POWER UP THE MONITOR. THE PATIENT WAS ISSUED TWO REPLACEMENT BATTERY PACKS AND A BATTERY CHARGER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR |