FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2123519
·
Received June 8, 2011
Report
- Report Number
- 3008642652-2011-00021
- Event Type
- Malfunction
- Date Received
- June 8, 2011
- Date of Event
- April 5, 2011
- Report Date
- June 8, 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/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CHARGER WON'T LIGHT UP) HAS BEEN CONFIRMED. UPON EVAL, THE POWER BRICK CONNECTOR WOULD NOT STAY CONNECTED TO THE CHARGER. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER BRICK CONNECTOR. THE PT RECEIVED A REPLACEMENT BATTERY CHARGER.
Description of Event or Problem · 1
A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT WHEN HE PLUGGED IN THE CHARGER, IT DID NOT LIGHT UP. THE PT WAS ISSUED A REPLACEMENT CHARGER/MODEM.
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 | 66 YR |