FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2092269
·
Received April 27, 2011
Report
- Report Number
- 1720753-2011-06667
- Event Type
- Malfunction
- Date Received
- April 27, 2011
- Date of Event
- April 5, 2011
- Report Date
- April 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NV, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ON SITE INVESTIGATION. THE EXTENDED EXPOSURE WAS DISABLED IN THE UTILITY SUITE. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN THE FLUOROSCOPY BUTTON WAS PUSHED, THE 9900 SYSTEM WOULD DOUBLE EXPOSE. NO PATIENT INJURY WAS 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 |