FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2221456
·
Received August 17, 2011
Report
- Report Number
- 3008642652-2011-00464
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- June 25, 2011
- Report Date
- August 16, 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 EVAL SUMMARY: DEVICE EVAL OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (CODE 202) HAS BEEN CONFIRMED. THE CAUSE OF THE CODE 202 IS CORRUPTED FLASH PROGRAMMING. THE ROOT CAUSE OF THE CORRUPTED FLASH CANNOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE CORRUPTED FLASH. THE PT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A (B)(6) DISTRIBUTOR RETURNED A MONITOR THAT WAS GENERATING A CODE 202.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |