FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2881165
·
Received November 16, 2012
Report
- Report Number
- 3008642652-2012-03006
- Event Type
- Malfunction
- Date Received
- November 16, 2012
- Date of Event
- October 31, 2012
- Report Date
- November 8, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (DAMAGED BELT CONNECTOR) WAS CONFIRMED. AS RECEIVED, THE TRUNK CABLE CONNECTOR HOUSING WAS BROKEN. THE CONNECTOR LOCKING NUT WAS MISSING, WHICH WOULD PREVENT THE ELECTRODE BELT FROM PROPERLY SECURING INTO THE MONITOR. THE ROOT CAUSE FOR THE MISSING LOCKING NUT CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY PHYSICAL ABUSE. NO ADVERSE EVENT RESULTED FROM THE DAMAGED ELECTRODE BELT CONNECTOR. THE PT WAS ISSUED A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT THE ELECTRODE BELT CONNECTOR WAS DAMAGED. THE PT WAS ISSUED 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 | 65 YR |