FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2971222
·
Received February 1, 2013
Report
- Report Number
- 1720753-2013-01358
- Event Type
- Malfunction
- Date Received
- February 1, 2013
- Date of Event
- January 14, 2013
- Report Date
- February 2, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD AND BACKPLANE WERE REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY WOULD NOT DISPLAY FLUOROSCOPIC X-RAY. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 45388 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |