FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 12211086
·
Received July 22, 2021
Report
- Report Number
- 3008642652-2021-06249
- Event Type
- Malfunction
- Date Received
- July 22, 2021
- Date of Event
- July 7, 2021
- Report Date
- July 20, 2021
- Manufacturer
- ZOLL MANUFACTURING CORPORATION
- Product Code
- MVK
- UDI-DI
- 00855778005005
- 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 MONITOR SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (RESETS) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR WAS RESETTING. THE CAUSE FOR THE RESETS WAS ISOLATED TO A DEFECTIVE U104 PXA PROCESSOR ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE DEFECTIVE U104 PXA PROCESSOR COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENTS OCCURRED FROM THE MONITOR MALFUNCTION.
Description of Event or Problem · 1
A US DISTRIBUTOR REPORTED THAT A MONITOR WAS RESETTING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1111245 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |