FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 1993166
·
Received February 7, 2011
Report
- Report Number
- 1720753-2011-00991
- Event Type
- Malfunction
- Date Received
- February 7, 2011
- Date of Event
- January 15, 2011
- Report Date
- February 7, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE WORKSTATION BOARDS WERE RESEATED. ALSO, THE SYNC ON THE VIDEO SWITCH WAS ADJUSTED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |