FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 5171601
·
Received October 23, 2015
Report
- Report Number
- 3008642652-2015-06656
- Event Type
- Malfunction
- Date Received
- October 23, 2015
- Date of Event
- August 30, 2015
- Report Date
- October 19, 2015
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION OF ELECTRODE BELT SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO COMMUNICATE WITH MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A SHORTED U718 PROCESSOR ON THE DISTRIBUTION NODE PCA. THE ROOT CAUSE FOR THE SHORTED COMPONENT COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE ELECTRODE BELT.
Description of Event or Problem · 1
A US DISTRIBUTOR RETURNED ELECTRODE BELT SN (B)(4) AND REPORTED THAT THE ELECTRODE BELT WAS UNABLE TO COMMUNICATE WITH A MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 701014 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |