FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2031303
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02406
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- August 4, 2009
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR INTERFACE BOARD AND BACKPLANE WERE REPLACED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM CONTINUED TO INDICATE X-RAY AFTER THE BUTTON WAS RELEASED DURING A CASE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |