FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2903366
·
Received December 14, 2012
Report
- Report Number
- 1720753-2012-10472
- Event Type
- Malfunction
- Date Received
- December 14, 2012
- Date of Event
- December 5, 2012
- Report Date
- December 14, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SYSTEM WAS RESET. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM DISPLAYED AN INTERMITTENT COMMUNICATION ERROR MESSAGE THAT WOULD EITHER PREVENT THE SYSTEM FROM BOOTING UP OR CAUSE THE SYSTEM TO STOP EXPOSING. THERE IS NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |