FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2946261
·
Received January 4, 2013
Report
- Report Number
- 3008642652-2012-03413
- Event Type
- Malfunction
- Date Received
- January 4, 2013
- Date of Event
- December 11, 2012
- Report Date
- December 31, 2012
- 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED CABLES) HAS BEEN CONFIRMED. UPON INVESTIGATION THE DISTRIBUTION NODE (DN) TO REAR THERAPY ELECTRODE CABLE WAS PULLED FROM THE STRAIN RELIEF. THE ROOT CAUSE FOR THE STRAINED CABLE COULD NOT BE POSITIVELY IDENTIFIED, BUT THE DAMAGE WAS LIKELY CAUSED BY EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT.
Description of Event or Problem · 1
A ZOLL PT SERVICE REP (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT THAT (B)(6) MALE PT'S ELECTRODE BELT CABLE WAS DAMAGED. THE PT ENDED USE AND DID NOT REQUIRE A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 5075 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |