FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 400 SYSTEM
MDR report key: 4093069
·
Received September 10, 2014
Report
- Report Number
- 3008642652-2014-02781
- 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 THE ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO COMMUNICATE WITH A MONITOR) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THERE WAS AN OPEN ALONG THE ORANGE (+5V) WIRE OF THE TRUNK CABLE. THE CAUSE OF THE TEST FAILURE IS THE OPEN +5V WIRE. THE ROOT CAUSE OF THE OPEN WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON THE CABLE. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT ELECTRODE BELT SN (B)(4) WOULD NOT COMMUNICATE WITH A MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 559628 | LIFEVEST WCD 400 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |