FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4210352
·
Received August 8, 2014
Report
- Report Number
- 3008642652-2014-02399
- Event Type
- Malfunction
- Date Received
- August 8, 2014
- Date of Event
- July 9, 2014
- Report Date
- August 6, 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 EVALUATION SUMMARY: DEVICE EVALUATION OF MONITOR SN (B)(4) IS CURRENTLY UNDERWAY. THE REPORTED PROBLEM (UNABLE TO RUN DETECT AND TREAT TEST) WAS CONFIRMED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONAL TESTING. A ROOT CAUSE INVESTIGATION IS CURRENTLY UNDERWAY. A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A U.S. DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT MONITOR SN (B)(4) WAS UNABLE TO RUN A DETECT AND TREAT TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 470559 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |