FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2223067
·
Received August 10, 2011
Report
- Report Number
- 1720753-2011-20920
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- August 2, 2011
- Report Date
- August 10, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN OUTSIDE INVESTIGATION. THE ISSUE COULD NOT BE DUPLICATED. THE GENERATOR INTERFACE BOARD AND THE FLUORO FUNCTIONS BOARD PCBS WERE RESEATED. THE SYSTEM'S SOFTWARE WAS RELOADED. 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 KEPT BOOTING ITSELF UP. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |