FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2890844
·
Received November 21, 2012
Report
- Report Number
- 3008642652-2012-03087
- Event Type
- Malfunction
- Date Received
- November 21, 2012
- Date of Event
- September 29, 2012
- Report Date
- November 21, 2012
- 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 CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DOESN'T WORK) HAS BEEN CONFIRMED. UPON EVALUATION, THERE WAS NO DC VOLTAGE OUTPUT FROM THE POWER SUPPLY UNIT. THE ROOT CAUSE OF THE DEFECTIVE POWER SUPPLY CONNECTOR CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY. THE PT WAS ISSUED A REPLACEMENT BATTERY CHARGER.
Description of Event or Problem · 1
AN ACCOUNT COORDINATOR CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT WHILE FITTING A (B)(6) MALE PT, THE CHARGER/MODEM DID NOT WORK. THE PT WAS ISSUED A REPLACEMENT 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 | 62 YR |