FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4214778
·
Received October 1, 2014
Report
- Report Number
- 3008642652-2014-03060
- Event Type
- Malfunction
- Date Received
- October 1, 2014
- Date of Event
- September 2, 2014
- Report Date
- September 29, 2014
- Manufacturer
- ZOLL MANUFACTURING CORP
- 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 OF ELECTRODE BELT SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (NON-FUNCTIONAL TES) WAS CONFIRMED. AS RECEIVED, THE ELECTRODE BELT FAILED INCOMING TESTING. UPON INVESTIGATION, THE CABLE CONNECTING THE DISTRIBUTION NODE (DN) TO REAR THERAPY PAD (TE WAS PULLED FROM THE STRAIN RELIEF. THE CAUSE OF THE TEST FAILURE WAS THE PULLED DN TO REAR TE CABLE. THE ROOT CAUSE OF THE PULLED DN TO REAR TE CABLE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY DU TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FORM THE DAMAGED BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) HAD NON-FUNCTIONAL THERAPY ELECTRODES (TES).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 610973 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR MVK | MVK | ZOLL MANUFACTURING CORP | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |