FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1982142
·
Received January 17, 2011
Report
- Report Number
- 3002158293-2011-00057
- Event Type
- Malfunction
- Date Received
- January 17, 2011
- Date of Event
- December 14, 2010
- Report Date
- January 14, 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 ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED TRUNK CONNECTOR) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE CONNECTOR WAS DAMAGED. THE CAUSE FOR THE DAMAGED CONNECTOR CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BROKEN CONNECTOR. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) YEAR OLD MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT AN UNRELATED PROBLEM WITH HIS BELT. UPON SERVICING, THE BELT WAS FOUND TO HAVE A DAMAGED TRUNK CONNECTOR. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.
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 | 66 YR |