FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2891585
·
Received December 7, 2012
Report
- Report Number
- 1720753-2012-10205
- Event Type
- Malfunction
- Date Received
- December 7, 2012
- Date of Event
- November 7, 2012
- Report Date
- December 7, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE SYSTEM SOFTWARE WAS RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED COLLIMATOR FILAMENT AND CAMERA IRIS CALIBRATION REQUIRED ERROR MESSAGES THAT PREVENTED THE SYSTEM FROM COMPLETING BOOT UP. THERE IS NOR REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |