FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2971758
·
Received February 6, 2013
Report
- Report Number
- 9680959-2013-00303
- Event Type
- Malfunction
- Date Received
- February 6, 2013
- Date of Event
- November 12, 2012
- Report Date
- February 6, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE EVALUATED THE SYS AND COULD NOT REPRODUCE THE REPORTED PROBLEM. THE SYSTEM OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYS DISPLAYED A "HIGH MA" ERROR. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 51392 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |