FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4259341
·
Received November 12, 2014
Report
- Report Number
- 3008642652-2014-03816
- 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 ECGS) HAS BEEN CONFIRMED. AS RECEIVED, THE BELT FAILED INCOMING TESTING. UPON EVALUATION,T HERE WAS AN OPEN ALONG THE WHITE (DRVN GND) WIRE OF THE TRUNK CABLE. THE CAUSE OF THE NON-FUNCTIONAL ECGS IS THE OPEN WIRE. THE ROOT CAUSE OF THE OPEN WIRE CANNOT BE POSITIVELY IDENTIFIED BUT IS LIKELY EXCESSIVE FORCE PLACED ON T HE CABLE. NO ADVERSE EVENT RESULTED FORM 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 ECG'S.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 728039 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORP | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |