FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 4232470
·
Received September 17, 2014
Report
- Report Number
- 3008642652-2014-02844
- Event Type
- Malfunction
- Date Received
- September 17, 2014
- Date of Event
- August 18, 2014
- Report Date
- September 11, 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 OF BATTERY PACK SN (B)(4) WAS COMPLETED. THE REPORTED PROBLEM (DOES NOT POWER ON MONITOR) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY PACK WAS UNABLE TO RECHARGE OR POWER UP A MONITOR. THE BATTERY WAS PRODUCING A BATTERY FAULT AND HAD AN OUTPUT VOLTAGE OF 2V. THE ROOT CAUSE FOR THE FAILURE COULD NOT BE POSITIVELY IDENTIFIED BUT WAS LIKELY DEFECTIVE BATTERY CELLS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.
Description of Event or Problem · 1
A ZOLL DISTRIBUTOR RETURNED A BATTERY PACK INDICATING THAT THE BATTERY WAS UNABLE TO POWER ON A MONITOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 574487 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |