FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2011985
·
Received February 14, 2011
Report
- Report Number
- 3002158293-2011-00137
- Event Type
- Malfunction
- Date Received
- February 14, 2011
- Date of Event
- December 16, 2010
- Report Date
- February 5, 2011
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF ELECTRODE BELT (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BROKEN TRUNK CONNECTOR) HAS BEEN CONFIRMED. UPON EVALUATION 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 LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY PROBLEMS.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING OF ELECTRODE BELT (B)(4), WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE BELT HAD A BROKEN TRUNK CABLE CONNECTOR. THE LAST PATIENT TO USE THIS BELT DID NOT REPORT ANY PROBLEMS WITH IT.
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 | NA |