FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3100 SYSTEM
MDR report key: 2002666
·
Received February 9, 2011
Report
- Report Number
- 3002158293-2011-00145
- Event Type
- Malfunction
- Date Received
- February 9, 2011
- Date of Event
- December 12, 2010
- Report Date
- February 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEMS (DAMAGED CASE/ WILL NOT POWER ON) HAVE BEEN CONFIRMED. UPON EVAL, THE END CAP APPEARED TO HAVE BEEN GLUED. THE WHITE CABLE BECAME DISCONNECTED FROM J2008 CAUSING THE MONITOR NOT TO POWER UP. THE CAUSE FOR THE DISCONNECTED CABLE CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DISCONNECTED CABLE. THE PT WAS ISSUED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
THE HUSBAND OF A (B)(6) FEMALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE PT'S MONITOR SEPARATED INTO TWO PIECES. THE PT RECONNECTED THE SEPARATED PIECES BUT THE MONITOR WOULD NOT POWER UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3100 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3100 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 34 YR |