FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2192855
·
Received July 25, 2011
Report
- Report Number
- 1720753-2011-20370
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- July 13, 2011
- Report Date
- July 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE GENERATOR INTERFACE BOARD WAS REPAIRED AND THE BACKPLANE WAS REPLACED. THE SYS WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYS DISPLAYED A COMMUNICATION ERROR MESSAGE AND WOULD NOT COMPLETE THE BOOT UP PROCESS. 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 |