FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2241499
·
Received August 9, 2011
Report
- Report Number
- 3008642652-2011-00401
- Event Type
- Malfunction
- Date Received
- August 9, 2011
- Date of Event
- June 24, 2011
- Report Date
- August 8, 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 (MONITOR UNABLE TO POWER ON) HAS BEEN CONFIRMED. THE CAUSE OF THE RESETS HAS BEEN ISOLATED TO CORRUPT PROGRAMMING OF THE FLASH MEMORY. THE ROOT CAUSE FOR THE CORRUPT PROGRAMMING CANNOT BE POSITIVELY DETERMINED. 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'S FRIEND CONTACTED ZOLL CUSTOMER SUPPORT TO REPORT THE PT'S MONITOR WAS UNABLE TO POWER ON WHEN THE BATTERY WAS INSERTED. 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 CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR |