FDA Adverse Event
Malfunction
Summary report: N
FLUOROSCOPIC X-RAY
MDR report key: 2971432
·
Received October 4, 2007
Report
- Report Number
- 1720753-2007-08957
- Event Type
- Malfunction
- Date Received
- October 4, 2007
- Date of Event
- September 14, 2007
- Report Date
- October 4, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE ERROR COULD NOT BE DUPLICATED. HOWEVER, TO MAKE SYSTEM COMPATIBLE WITH NEW SOFTWARE, REPLACED CINE DRIVE, CPU, DISPLAY ADAPTER, GIB, HARD DRIVE, SYSTEM INTERFACE AND POWER CABLE. 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 A CINE NOT AVAILABLE ERROR WAS DISPLAYED ON THE 9800 SYSTEM WHEN THE UNIT WAS TURNED ON. THE CASE WAS FINISHED WITHOUT CINE. ERROR CLEARED WHEN OK WAS SELECTED. THERE WAS 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 | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |