FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2010321
·
Received February 11, 2011
Report
- Report Number
- 3002158293-2011-00157
- Event Type
- Malfunction
- Date Received
- February 11, 2011
- Date of Event
- January 4, 2011
- Report Date
- February 9, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BENT PINS OR DAMAGED E-BELT CONNECTOR) HAS BEEN CONFIRMED. UPON EVALUATION PINS IN THE ELECTRODE BELT'S TRUNK CABLE CONNECTOR WERE BENT IN A SWIRL PATTERN. THE CAUSE FOR THE BENT PINS CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT CONNECTOR. THE PT REC'D A REPLACEMENT ELECTRODE BELT.
Description of Event or Problem · 1
A PT SERVICE REP (PSR) CONTACTED ZOLL CUSTOMER SUPPORT WHILE ASSISTING AN (B)(6) MALE PT TO REPORT THAT THE PATIENT'S ELECTRODE BELT WOULD NOT CONNECT TO THE MONITOR BECAUSE CONNECTOR PINS WERE BENT. THE PT WAS PROVIDED WITH 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 | 80 YR |