FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4862632
·
Received June 18, 2015
Report
- Report Number
- 3008642652-2015-03932
- Event Type
- Malfunction
- Date Received
- June 18, 2015
- Date of Event
- May 30, 2015
- Report Date
- June 17, 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
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION OF BATTERY CHARGER/MODEM (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (UNABLE TO CHARGE A BATTERY PACK) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY CHARGER/ MODEM WAS UNABLE TO CHARGE A BATTERY PACK. THE CAUSE FOR THE FAILURE WAS ISOLATED TO A CONTAMINATED BATTERY BOARD. THE ROOT CAUSE FOR THE CONTAMINATION WAS DUE TO AN INGRESS OF AN UNK LIQUID. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY CHARGER/MODEM.
Description of Event or Problem · 1
A ZOLL DISTRIBUTOR RETURNED BATTERY CHARGER/MODEM (B)(4) TO REPORT THAT THE BATTERY CHARGER WAS UNABLE TO CHARGE A BATTERY PACK.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 397386 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |