FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 7086180
·
Received December 6, 2017
Report
- Report Number
- 3008642652-2017-10211
- Event Type
- Malfunction
- Date Received
- December 6, 2017
- Date of Event
- October 21, 2017
- Report Date
- December 5, 2017
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005036
- 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 BATTERY SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (BATTERY FAULTS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE BATTERY WAS UNABLE TO POWER ON A MONITOR OR CHARGE. THE CAUSE FOR THE FAILURE WAS ISOLATED OT A DEPLETED TRI-CELL (0.012V). THE ROOT CAUSE OF THE DEFECTIVE TRI-CELL WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE BATTERY PACK.
Description of Event or Problem · 1
A US DISTRIBUTOR REPORTED THAT A PATIENT WAS RECEIVING BATTERY FAULTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 867158 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005036 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |