FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 2221465
·
Received August 17, 2011
Report
- Report Number
- 3008642652-2011-00453
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- March 29, 2011
- Report Date
- August 12, 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 EVAL SUMMARY: DEVICE EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (TRUNK CONNECTOR PINS BENT) HAS BEEN CONFIRMED. UPON EVAL, THE TRUNK CABLE CONNECTOR PINS WERE BENT. THE CAUSE FOR THE BENT CONNECTOR PINS CANNOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY THE RESULT OF EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FROM THE BENT CONNECTOR PINS. THE LAST PT 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 SN (B)(4) WHICH WAS RETURNED FOR ROUTINE MAINTENANCE, IT WAS DISCOVERED THAT THE BELT HAD BENT PINS IN THE TRUNK CABLE CONNECTOR. THE LAST PT 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 |