FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2210367
·
Received August 8, 2011
Report
- Report Number
- 1720753-2011-20815
- Event Type
- Malfunction
- Date Received
- August 8, 2011
- Date of Event
- July 28, 2011
- Report Date
- August 8, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE FLUORO FUNCTIONS BOARD PCB AND THE GENERATOR INTERFACE BOARD PCB WERE RESEATED. ALL THE CABLES TIED INTO THE COLLIMATOR IRIS WERE RESEATED AND THE COLLIMATOR IRIS WAS CALIBRATED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THE MALFUNCTION MAY HAVE RESULTED IN AN ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A POTENTIOMETER ERROR AND WOULD HAVE TO REBOOT. NO PT INJURY IS REPORTED.
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 |