FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2041446
·
Received March 10, 2011
Report
- Report Number
- 3002158293-2011-00270
- Event Type
- Malfunction
- Date Received
- March 10, 2011
- Date of Event
- January 16, 2011
- Report Date
- March 7, 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (WILL NOT POWER UP) WAS CONFIRMED. THE CAUSE FOR THE CHARGER/MODEM NOT POWERING UP WAS A DEFECTIVE POWER BRICK. THE ROOT CAUSE OF THE DEFECTIVE POWER BRICK CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE POWER BRICK. THE PATIENT RECEIVED A REPLACEMENT BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
THE PATIENT SERVICE REPRESENTATIVE (PSR) ASSISTING AN (B)(6) FEMALE PATIENT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PATIENT'S BATTERY CHARGER/MODEM WOULD NOT POWER UP. 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 | 87 YR |