FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4250204
·
Received November 6, 2014
Report
- Report Number
- 3008642652-2014-03699
- Event Type
- Malfunction
- Date Received
- November 6, 2014
- Date of Event
- October 11, 2014
- Report Date
- November 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 EVAL OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (THERAPY ELECTRODES NOT FUNCTIONING ) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT FAILED INCOMING FUNCTIONALITY TESTING. THE CAUSE FOR THE FAILURE WAS ISOLATED TO AN INTERMITTENT SOLDER CONNECTION ON CONNECTOR J2 INSIDE OF THE FRONT THERAPY ELECTRODE. THE ROOT CAUSE FOR THE INTERMITTENT CONNECTION WAS AN ASSEMBLY ERROR. A CORRECTIVE ACTION HAS BEEN INITIATED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A ZOLL DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) TO REPORT THAT THE ELECTRODE BELT THERAPY ELECTRODES WERE NOT FUNCTIONING PROPERLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 714956 | LIFEVEST WCD 4000 SYSTEM | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |