FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2243640
·
Received August 24, 2011
Report
- Report Number
- 1720753-2011-21345
- Event Type
- Malfunction
- Date Received
- August 24, 2011
- Date of Event
- August 16, 2011
- Report Date
- August 24, 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 REP PERFORMED AN ONSITE INVESTIGATION. THE PS3 WAS ADJUSTED AND THE HARD DRIVE WAS RECOVERED DURING THE BOOT SEQUENCE. 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 THERE WAS NO IMAGE ON THE MONITOR, A SYSTEM DISC FAILURE ERROR DISPLAYED AND THE SYSTEM WOULD NOT REBOOT. 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 |