FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4259330
·
Received November 12, 2014
Report
- Report Number
- 3008642652-2014-03824
- Event Type
- Malfunction
- Date Received
- November 12, 2014
- Date of Event
- October 13, 2014
- Report Date
- November 7, 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) HAS BEEN COMPLETED. THE REPORTED PROBLEM (NON-FUNCTIONAL TES) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION, THERE WAS AN INTERMITTENT OPEN ALONG THE FRONT PULSE WIRE BETWEEN THE DN AND ECG 'B'. THE CAUSE OF THE NON-FUNCTIONAL TES IS THE OPEN PULSE 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) HAD NON-FUNCTIONAL TES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 728163 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILALTOR | MVK | ZOLL MANUFACTURING CORP | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |