FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2091441
·
Received May 6, 2011
Report
- Report Number
- 3002158293-2011-00515
- Event Type
- Malfunction
- Date Received
- May 6, 2011
- Date of Event
- March 26, 2011
- Report Date
- May 5, 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 OF BATTERY CHARGER/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) HAS BEEN CONFIRMED. UPON EVALUATION, THE CHARGER/MODEM WAS FOUND TO HAVE DEFECTIVE RAM (COMPONENTS U100 AND U101). THE CAUSE FOR THE DEFECTIVE RAM CANNOT BE POSITIVELY DETERMINED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE RAM. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
A PATIENT SERVICE REPRESENTATIVE (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING A (B)(6) MALE PATIENT TO REPORT THAT THE PATIENT'S BATTERY CHARGER/MODEM WOULD NOT WORK. 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 | 72 YR |