FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 3941564
·
Received April 17, 2014
Report
- Report Number
- 3008642652-2014-01182
- Event Type
- Malfunction
- Date Received
- April 17, 2014
- Date of Event
- March 22, 2014
- Report Date
- April 14, 2014
- Manufacturer
- ZOLL LIFECOR CORPORATION
- Product Code
- MVK
- PMA / PMN Number
- P010030
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DEVICE EVALUATION SUMMARY: DEVICE EVALUATION OF BATTERY PACK SN (B)(4) HAS BEEN COMPLETED. AS RECEIVED, THE BATTERY WAS UNABLE TO POWER ON A MONITOR. REVIEW OF THE FLAG FILES CONFIRMED THE BATTERY WAS UNABLE TO HOLD A CHARGE FOR 24 HOURS. THE BATTERY WAS SCRAPPED BEFORE AN INVESTIGATION COULD BE COMPLETED. THE LIKELY CAUSE OF THE INABILITY TO HOLD A CHARGE WAS DEFECTIVE BATTERY CELLS. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK. THE LAST PATIENT TO USE THIS BATTERY DID NOT REPORT ANY DEFICIENCIES.
Description of Event or Problem · 1
A REVIEW OF SERVICE DATA DETECTED A REPORTABLE EVENT. UPON SERVICING BATTERY PACK SN (B)(4), THE BATTERY WAS UNABLE TO POWER ON A MONITOR. THE LAST PATIENT TO USE THIS BATTERY DID NOT REPORT ANY DEFICIENCIES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 235565 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL LIFECOR CORPORATION | WCD 4000 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |