FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3002557
·
Received February 15, 2013
Report
- Report Number
- 3008642652-2013-00406
- Event Type
- Malfunction
- Date Received
- February 15, 2013
- Date of Event
- January 26, 2013
- Report Date
- February 11, 2013
- 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CONNECTOR) WAS CONFIRMED. UPON INVESTIGATION THE MONITOR'S ELECTRODE BELT CONNECTOR WAS BROKEN FREE FROM THE MONITOR CASE, DAMAGING THE WIRES INSIDE OF THE CONNECTOR. THE ROOT CAUSE FOR THE DAMAGED CONNECTOR COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE LIKELY RESULTED FROM THE MONITOR BEING DROPPED WHILE CONNECTED TO AN ELECTRODE BELT. NO ADVERSE EVENT RESULTED FROM THE DAMAGED CONNECTOR. THE PATIENT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
THE WIFE OF A (B)(6) MALE PATIENT CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE ELECTRODE BELT CONNECTOR ON THE PATIENT'S MONITOR WAS DAMAGED. THE PATIENT WAS ISSUED A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67592 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 54 YR |