FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4093054
·
Received September 10, 2014
Report
- Report Number
- 3008642652-2014-02770
- Event Type
- Malfunction
- Date Received
- September 10, 2014
- Date of Event
- August 15, 2014
- Report Date
- September 5, 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 ELECTRODE BELT SN (B)(4) IS COMPLETE. THE REPORTED PROBLEM (UNABLE TO PERFORM DETECT AND TREAT) 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 DUE TO EXCESSIVE FORCE. NO ADVERSE EVENT RESULTED FORM THE DAMAGE BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WAS UNABLE TO PERFORM THE DETECT AND TREAT TEST.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559623 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |