FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 2110356
·
Received April 21, 2011
Report
- Report Number
- 3002158293-2011-00460
- Event Type
- Malfunction
- Date Received
- April 21, 2011
- Date of Event
- February 14, 2011
- Report Date
- April 21, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 202) HAS BEEN CONFIRMED. UPON EVALUATION IT WAS FOUND THAT THE FLASH MEMORY CHIPS (B)(4) 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 PATIENT RECEIVED A REPLACEMENT MONITOR.
Description of Event or Problem · 1
A PATIENT SERVICE REPRESENTATIVE (PSR) CALLED ZOLL CUSTOMER SUPPORT TO REPORT A SERVICE CODE 202 WHEN THE MONITOR WAS POWERED ON. THE PATIENT SERVICE REPRESENTATIVE 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 | NA |