FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1970478
·
Received January 19, 2011
Report
- Report Number
- 3002158293-2011-00062
- Event Type
- Malfunction
- Date Received
- January 19, 2011
- Date of Event
- December 14, 2010
- Report Date
- January 17, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY CHARGER/MODEM SN (B)(6) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BLANK SCREEN/CONNECTOR WON'T FIT INTO CHARGER) HAS BEEN CONFIRMED. UPON EVALUATION 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 PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
THE SISTER OF A (B)(6) YEAR OLD MALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER/MODEM SCREEN WENT BLANK AND THAT THE POWER SUPPLY WILL NOT STAY SECURELY CONNECTED TO THE CHARGER. THE PATIENT WAS ISSUED A REPLACEMENT BATTERY 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 | 63 YR |