FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1901682
·
Received November 12, 2010
Report
- Report Number
- 3002158293-2010-01194
- Event Type
- Malfunction
- Date Received
- November 12, 2010
- Date of Event
- October 26, 2010
- Report Date
- November 9, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVAL SUMMARY: DEVICE EVAL OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. UPON EVAL, IT WAS DISCOVERED THAT THERE WAS A BROKEN WHITE WIRE ON THE BATTERY PCA BOARD WHERE THE WIRE ATTACHES THE BATTERY CELLS. THE ROOT CAUSE OF THE BROKEN WIRE HAS NOT BEEN DETERMINED BUT MAY HAVE BEEN CAUSED BY A SEVERE SHOCK FROM DROPPING THE PACK. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING BATTERY PACK SN (B)(4), FAILED INTERNAL RESISTANCE SCREENING. THE LAST PT TO USE THIS BATTERY PACK DID NOT REPORT ANY DEFICIENCIES.
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 | NA |