FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2072554
·
Received April 20, 2011
Report
- Report Number
- 3002158293-2011-00442
- Event Type
- Malfunction
- Date Received
- April 20, 2011
- Date of Event
- February 19, 2011
- Report Date
- April 19, 2011
- Manufacturer
- ZOLL LIFECOR CORP
- 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 MONITOR (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (MONITOR IS RESETTING) HAS BEEN CONFIRMED. UPON EVALUATION, IT WAS FOUND THAT THE FLASH MEMORY CHIPS (COMPONENTS U102 AND U105) WERE CORRUPT AND NEEDED REPLACED. THE ROOT CAUSE OF THE DEFECTIVE FLASH MEMORY CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPT MEMORY. THE PT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(6) MALE PT CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THAT HIS MONITOR KEPT REBOOTING. THE MONITOR WILL NOT POWER UP. THE PT WAS ISSUED A REPLACEMENT MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORP | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR |