FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 7236021
·
Received February 2, 2018
Report
- Report Number
- 3008642652-2017-10825
- Event Type
- Malfunction
- Date Received
- February 2, 2018
- Date of Event
- November 3, 2017
- Report Date
- January 21, 2018
- 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 (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 203/104) WAS INVESTIGATED. AS RECEIVED, THE MONITOR FAILED INCOMING FUNCTIONALITY TESTING. UPON INVESTIGATION, THERE WAS THERMAL DAMAGE TO MULTIPLE LOW VOLTAGE COMPONENTS. THE CAUSE OF THE FAILURE WAS ISOLATED TO A SHORTED IGBT Q17. THE SHORTED COMPONENT CAUSED HIGH VOLTAGE TO DEVIATE TO LOW VOLTAGE CIRCUITRY, DAMAGING MULTIPLE COMPONENTS ON THE DEFIBRILLATOR PCA AND COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE SHORTED Q17 WAS UNABLE TO BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A US DISTRIBUTOR REPORTED THAT A MONITOR PRODUCED A SERVICE CODE 203 AND SERVICE CODE 104.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 78984 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |