FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 901046
·
Received August 22, 2007
Report
- Report Number
- 1720753-2007-04528
- Event Type
- Malfunction
- Date Received
- August 22, 2007
- Date of Event
- June 19, 2007
- Report Date
- August 22, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE DESCRIBED FAILURE COULD NOT BE DUPLICATED. HOWEVER, FOUND THE 24V POWER SUPPLY WAS LOW. ADJUSTED THE POWER SUPPLY AND AS A PREVENTATIVE MEASURE RESEATED THE IMAGE FUNCTION BOARD (IFB). THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PLACED BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE 9600 SYSTEM EXPERIENCED AN IFB (IMAGE FUNCTION BOARD) AND INTERLOCK OPEN ERRORS WHILE FLUOROING. SYSTEM REBOOTED AND CASE CONTINUED. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9600 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |