FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2081009
·
Received April 14, 2011
Report
- Report Number
- 1720753-2011-03579
- Event Type
- Malfunction
- Date Received
- April 14, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 14, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE RESEATED THE FLUORO FUNCTIONS BOARD, CALIBRATED THE COLLIMATOR AND THE CAMERA, AND SAVED THE CALIBRATION FILES TO THE SYSTEM. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM DISPLAYED AN IRIS COLLIMATOR ERROR MESSAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 8900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |