FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 3000 SYSTEM
MDR report key: 1961455
·
Received January 10, 2011
Report
- Report Number
- 3002158293-2011-00008
- Event Type
- Malfunction
- Date Received
- January 10, 2011
- Date of Event
- November 12, 2010
- Report Date
- January 6, 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
- 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 A BROKEN TRUNK CABLE CONNECTOR. THERE WERE NO BENT PINS. THE ROOT CAUSE OF THE BROKEN CONNECTOR WAS NOT POSITIVELY IDENTIFIED, BUT WAS PROBABLY A RESULT OF EXCESSIVE FORCE APPLIED TO THE CONNECTOR DURING MATING. NO ADVERSE EVENT RESULTED FORM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING, ELECTRODE BELT (B)(4) WAS FOUND TO HAVE A BROKEN TRUNK CABLE CONNECTOR. THE LAST PT TO USE THIS ELECTRODE BELT DID NOT REPORT ANY DEFICIENCIES.
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 |