FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2770668
·
Received October 1, 2012
Report
- Report Number
- 1720753-2012-07799
- Event Type
- Malfunction
- Date Received
- October 1, 2012
- Date of Event
- September 21, 2012
- Report Date
- October 1, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE IMAGE PROCESSOR CIRCUIT BOARD WAS REPLACED AND THE VIDEO CONTROLLER BOARD VIDEO CONNECTIONS WERE RETIGHTENED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT DISPLAY THE LIVE IMAGE ON THE LEFT MONITOR. THERE IS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |