FDA Adverse Event
Malfunction
Summary report: N
LIFEVEST WCD 4000 SYSTEM
MDR report key: 7810593
·
Received August 23, 2018
Report
- Report Number
- 3008642652-2018-06903
- Event Type
- Malfunction
- Date Received
- August 23, 2018
- Date of Event
- July 1, 2018
- Report Date
- August 7, 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 SN (B)(4) HAS BEEN COMPLETED. THE REPORTED PROBLEM (SERVICE CODE 202/114) HAS BEEN CONFIRMED. UPON INVESTIGATION THE MONITOR DISPLAYED A SERVICE CODE 202/114. THE MONITOR EXHIBITED A FLASH MEMORY FAILURE AT BGA COMPONENTS U102 AND U105 ON THE COMPUTER/ANALOG BOARD. THE ROOT CAUSE FOR THE FLASH MEMORY FAILURE COULD NOT BE POSITIVELY IDENTIFIED. NO ADVERSE EVENT RESULTED FROM THE DEFECTIVE MONITOR.
Description of Event or Problem · 1
A US DISTRIBUTOR REPORTED THAT A PATIENT'S MONITOR WAS DISPLAYING A SERVICE CODE 202 (PATIENT PARAMETERS CORRUPT) AND A SERVICE CODE 114 (PARAMETERS DB RESTORED FROM BACKUP).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 652736 | LIFEVEST WCD 4000 SYSTEM | WEARABLE CARDIOVERTER DEFIBRILLATOR | MVK | ZOLL MANUFACTURING CORPORATION | WCD 4000 | 00855778005005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |