FDA Adverse Event
Malfunction
Summary report: N
GE OEC 9600
MDR report key: 892561
·
Received August 12, 2007
Report
- Report Number
- 1720753-2007-03984
- Event Type
- Malfunction
- Date Received
- August 12, 2007
- Date of Event
- July 16, 2007
- Report Date
- August 12, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- LA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REP INVESTIGATED THE ISSUE AND FOUND A DEFECTIVE FOOT SWITCH CONNECTION, AND DEFECTIVE ANALOG INTERFACE PCB. BOTH COMPONENTS WERE REPLACED. ADDITIONALLY, THERE WAS CONTAMINATION OF THE IFB PCB THAT WAS REPAIRED. THE SYSTEM WAS TESTED AND FOUND TO BE FUNCTIONING AS INTENDED. THE SYSTEM WAS RELEASED TO THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFO 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 9600 FLUOROSCOPY SYSTEM DISPLAYED AN IFB RESET ERROR CODE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |