FDA Adverse Event
Malfunction
Summary report: N
9400
MDR report key: 2031302
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02396
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- May 28, 2009
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE HARD DRIVE AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9400 SYSTEM HAD A DATA ERROR MESSAGE AND INTERMITTENTLY CONTINUES TO FLUORO WHEN THE FOOT SWITCH IS RELEASED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9400 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |