FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4181254
·
Received August 4, 2014
Report
- Report Number
- 3008642652-2014-02353
- Event Type
- Malfunction
- Date Received
- August 4, 2014
- Date of Event
- July 22, 2014
- Report Date
- July 30, 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 BATTERY CHARGER/MODEM SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY CHARGER/MODEM WILL NOT POWER UP) WAS CONFIRMED. UPON EVALUATION, THE BATTERY CHARGER/MODEM WAS UNABLE TO POWER UP. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A DEFECTIVE POWER SUPPLY BRICK. THE ROOT CAUSE FOR THE DEFECTIVE POWER SUPPLY COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
A US DISTRIBUTOR CONTACTED ZOLL TO REPORT THAT BATTERY CHARGER/MODEM SN (B)(4) WAS UNABLE TO POWER UP.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 453118 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |