FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1993189
·
Received February 7, 2011
Report
- Report Number
- 1720753-2011-00986
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 18, 2011
- Report Date
- February 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. DIAGNOSTIC TESTS WERE PERFORMED ON THE SYSTEM. THE REPORTED ISSUE COULD NOT BE IDENTIFIED NOR DUPLICATED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM DISPLAYED A COLLIMATOR ERROR MESSAGE. NO REPORT OF INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |