FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2935320
·
Received January 14, 2013
Report
- Report Number
- 1720753-2013-00599
- Event Type
- Malfunction
- Date Received
- January 14, 2013
- Date of Event
- December 31, 2012
- Report Date
- January 14, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON-SITE INVESTIGATION. THE FOLLOWING COMPONENTS WERE REPLACED: THE INFC BOARD, VIDEO CONTROLLER BOARD, IMAGE PROCESSOR BOARD, PS2 POWER SUPPLY AND LEFT MONITOR. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM BLACKED OUT AND SHUT DOWN. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21203 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |