FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2093399
·
Received May 4, 2011
Report
- Report Number
- 1720753-2011-06934
- Event Type
- Malfunction
- Date Received
- May 4, 2011
- Date of Event
- April 15, 2011
- Report Date
- May 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BATTERY PACK WAS REPLACED, THE HIGH VOLTAGE NOZZLES WERE REMOVED TO BE CLEANED AND LUBRICATED, AND THE FLUOROSCOPY PEDAL AND EXPOSURE HANDLE WERE REPLACED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM HAD AN OVERHEATING PROBLEM AND A FILAMENT ERROR. 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 (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |