FDA Adverse Event
Other
Summary report: N
GE OEC 9800
MDR report key: 906928
·
Received September 4, 2007
Report
- Report Number
- 1720753-2007-05081
- Event Type
- Other
- Date Received
- September 4, 2007
- Date of Event
- August 13, 2007
- Report Date
- September 3, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND THE CUSTOMER WAS NOT FOLLOWING SYSTEM SHUTDOWN PROCEDURES AND CORRUPTED THE SYSTEM SOFTWARE, SOFTWARE WAS RE-LOADED AND FUNCTION RESTORED. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFORMATION WITH RESPECT TO THIS ISSUE. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.
Description of Event or Problem · 1
THE GE OEC 9800 FLUOROSCOPY SYSTEM HAD REPORTED ISSUE WITH DATA LOSS. SOME PT FILES WERE NOT PRESENT WHEN IMAGE DIRECTORY WAS ACCESSED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |