FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 1904159
·
Received November 15, 2010
Report
- Report Number
- 3002158293-2010-01183
- Event Type
- Malfunction
- Date Received
- November 15, 2010
- Date of Event
- October 25, 2010
- Report Date
- November 8, 2010
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
EVALUATION SUMMARY: DEVICE EVALUATION OF CHARGER (B)(4) HAS BEEN COMPLETED. UPON EVALUATION, THE CHARGER WAS FOUND TO HAVE DEFECTIVE COMPONENTS. 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.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. DURING SERVICING CHARGER (B)(4) WAS UNABLE TO POWER UP. THE LAST PT TO USE THIS CHARGER DID NOT REPORT ANY DEFICIENCIES.
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 |