FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1843673
·
Received September 21, 2010
Report
- Report Number
- 3002158293-2010-00947
- Event Type
- Malfunction
- Date Received
- September 21, 2010
- Date of Event
- September 10, 2010
- Report Date
- September 17, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER (B)(4) HAS BEEN COMPLETED. UPON EVALUATION THE POWER BRICK WAS FOUND TO BE DEFECTIVE. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CANNOT POSITIVELY BE DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, CHARGER (B)(4) WAS FOUND TO HAVE A DEFECTIVE POWER BRICK. THE LAST PT TO USE THIS CHARGER DID NOT REPORT ANY DEFICIENCIES.
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 | UNK |