FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4231895
·
Received October 17, 2014
Report
- Report Number
- 3008642652-2014-03387
- Event Type
- Malfunction
- Date Received
- October 17, 2014
- Date of Event
- August 29, 2014
- Report Date
- October 17, 2014
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- 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 (FAILED INCOMING FUNCTIONALITY TESTING) HAS BEEN CONFIRMED. UPON EVAL, THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE INCOMING FUNCTIONALITY TEST FAILURE WAS ISOLATED TO A POOR CONNECTION BETWEEN THE DEFIBRILLATOR AND C/A BOARDS. THE POOR CONNECTION WAS CAUSED BY DIRTY PINS ON CONNECTORS J1002AA AND J1003AA. THE ROOT CAUSE FOR THE DIRTY PINS COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTS FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A US DISTRIBUTOR RETURNED MONITOR SN (B)(4) TO REPORT THAT IT FAILED INCOMING FUNCTIONALITY TESTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 662506 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |