FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2884884
·
Received December 4, 2012
Report
- Report Number
- 9680959-2012-01671
- Event Type
- Malfunction
- Date Received
- December 4, 2012
- Date of Event
- November 15, 2012
- Report Date
- December 4, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE INTERCONNECT CABLE WAS REPLACED 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
THE CUSTOMER REPORTED AN ISSUE WITH THE INTERCONNECT CABLE AND THAT SOMETIMES NO IMAGES WERE DISPLAYED. THERE IS NO REPORT OF PT INJURY OR DEATH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |