FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3792511
·
Received January 18, 2014
Report
- Report Number
- 1720753-2014-00606
- Event Type
- Malfunction
- Date Received
- January 18, 2014
- Date of Event
- December 12, 2013
- Report Date
- January 17, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE GENERATOR INTERFACE BOARD AND THE SOFTWARE UPGRADE WERE INSTALLED DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
IT WAS REPORTED THE SYSTEM TO FUNCTION ATTRIBUTED TO A DATA ERROR MESSAGE. THERE ARE NO REPORTS OF PATIENT INJURY OR DEATH ASSOCIATED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 46523 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |