FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9900
MDR report key: 1153584
·
Received September 11, 2008
Report
- Report Number
- 1720753-2008-22267
- Event Type
- Malfunction
- Date Received
- September 11, 2008
- Date of Event
- May 27, 2008
- Report Date
- June 6, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP FOUND ERROR ON GPOS CREEN IN THE LINUX BOOT [FAILED] MESSAGE. ALSO CHECKED VOLTAGES INSIDE THE WORKSTATION AND ALL CHECKED WITHIN SPEC. UNIT WIULD NOT BOOT UP PASSED THAT PONT. THE REP RELOADED SW THEN UNIT WOULD BOOT UP NORMALLY, THIS ACTION TOOK CARE OF THE NO BOOT UP PROBLEM. VERIFIED THAT THE UNIT OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM WILL NOT BOOT. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |