FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2031267
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02382
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE GE REPRESENTATIVE CONDUCTED AN ONSITE INVESTIGATION AND THE SYSTEM ERROR COULD NOT BE REPRODUCED. THE LED'S AND POWER SUPPLY WERE CHECKED AND THE SOFTWARE RELOADED. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9900 SYSTEM WOULD NOT BOOT 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 |