FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1961454
·
Received January 10, 2011
Report
- Report Number
- 3002158293-2011-00021
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 22, 2010
- Report Date
- January 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 ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. UPON INSPECTION, THE ELECTRODE BELT WAS FOUND TO HAVE THE CONNECTOR PINS BENT IN A SWIRL PATTERN. THE ELECTRODE BELT CONNECTOR PINS DID NOT SUCCESSFULLY MATE WITH THE CONNECTOR. THE ROOT CAUSE OF THE BENT PINS CANNOT BE POSITIVELY IDENTIFIED, BUT WAS LIKELY DUE TO THE CONNECTOR BEING FORCED INTO THE MONITOR WHILE THE PINS WERE MISALIGNED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT. THE PT RECEIVED A REPLACEMENT BELT.
Description of Event or Problem · 1
A TERRITORY MANAGER ASSISTING A (B)(6) MALE PT CONTACTED ZOLL LIFECOR CUSTOMER SUPPORT TO REPORT THAT THERE WERE BENT PINS IN A PT'S ELECTRODE BELT. THE PT WAS SENT A REPLACEMENT ELECTRODE BELT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 3000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 3000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 47 YR |