FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1972696
·
Received January 20, 2011
Report
- Report Number
- 3002158293-2011-00070
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 12, 2010
- Report Date
- January 18, 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 (SERVICE CODE 204) HAS BEEN CONFIRMED. UPON EVAL IT WAS DISCOVERED THAT THE TRUNK CABLE INTERMITTENTLY LOSES SIGNAL WHEN FLEXED. THE CAUSE FOR THE INTERMITTENT SIGNAL LOSS CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DUE TO DAMAGED INTERNAL WIRING. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A REVIEW OF A (B)(6) YEAR OLD MALE PT'S DOWNLOAD REVEALED SEVERAL SERVICE CODES (204) AND CAN COMM TIMEOUTS. ZOLL CUSTOMER SUPPORT CONTACTED THE PT AND 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 | 49 YR |