FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2121424
·
Received May 6, 2011
Report
- Report Number
- 3002158293-2011-00512
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- February 18, 2011
- Report Date
- May 4, 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 EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (BATTERY NOT HOLDING A CHARGE) HAS BEEN CONFIRMED. A ROOT CAUSE ANALYSIS IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SENT UPON COMPLETION OF EVAL. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE PT RECEIVED A REPLACEMENT BATTERY PACK.
Description of Event or Problem · 1
A (B)(6) FEMALE PT, CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HONE OF HER BATTERIES WOULD NOT POWER UP A MONITOR. A SUBSEQUENT DOWNLOAD SHOWED THE BATTERY WAS NOT HOLDING A CHARGE. THE PT WAS ISSUED A REPLACEMENT BATTERY PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE COARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR |