FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2961680
·
Received February 11, 2013
Report
- Report Number
- 1720753-2013-01624
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Date of Event
- January 28, 2013
- Report Date
- February 11, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE REPRESENTATIVE EVALUATED THE SYSTEM AND THE FAILURE WAS TRACED TO A FAULTY CPU BATTERY WHICH CAUSED A LOSS OF GENERATOR DATA (CALIBRATION FILES). THE BATTERY WAS REPLACED AND THE CALIBRATION FILES WERE RELOADED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE COLLIMATOR CLOSED DOWN AND THE SYSTEM WOULD NOT DISPLAY A USABLE IMAGE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 60083 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |