FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2233016
·
Received July 20, 2011
Report
- Report Number
- 3008642652-2011-00260
- Event Type
- Malfunction
- Date Received
- July 20, 2011
- Date of Event
- May 20, 2011
- Report Date
- July 20, 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 CHARGER SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER PROBLEM) HAS BEEN CONFIRMED. AS RECEIVED, THE CHARGER WOULD NOT POWER UP. THE CAUSE OF THE PROBLEM IS DUE TO DISCONNECTED PINS IN THE CHARGER'S POWER SUPPLY CONNECTOR. THE ROOT CAUSE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER SUPPLY CONNECTOR.
Description of Event or Problem · 1
A (B)(6) DISTRIBUTOR SHIPPED BACK A DEFECTIVE BATTERY CHARGER.
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 |