FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3060869
·
Received April 5, 2013
Report
- Report Number
- 1720753-2013-04656
- Event Type
- Malfunction
- Date Received
- April 5, 2013
- Date of Event
- March 12, 2013
- Report Date
- April 5, 2013
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE CALIBRATION FILES WERE RELOADED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WAS ASKING FOR CALIBRATIONS TO BE PERFORMED AT BOOT UP. THIS ISSUE RENDERED THE SYSTEM UNUSABLE. THERE IS NO REPORT OF PT INJURY ASSOCIATES WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 139976 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |