FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2042951
·
Received March 25, 2011
Report
- Report Number
- 1720753-2011-02849
- Event Type
- Malfunction
- Date Received
- March 25, 2011
- Date of Event
- March 15, 2011
- Report Date
- March 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. FILE SYSTEM CHECK AND SYSTEM FILES CORRUPTED MESSAGES WERE DISPLAYED. THE SOFTWARE SYSTEM WAS RELOADED. THE FLASH MEMORY AND SYSTEM CALIBRATION FILES WERE RELOADED. THE SYSTEM AND FLUORO FUNCTION WERE TESTED AND THEY OPERATE AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9900 SYSTEM PRODUCED A FILE SYSTEM ERROR AND WENT DOWN DURING A CASE. NO PT INJURY WAS REPORTED AND DIFFERENT UNIT WAS USED TO COMPLETE THE CASE.
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 |