FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2770702
·
Received October 1, 2012
Report
- Report Number
- 9680959-2012-01214
- Event Type
- Malfunction
- Date Received
- October 1, 2012
- Date of Event
- September 24, 2012
- Report Date
- October 1, 2012
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE HAND SWITCH 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 THAT THE SYSTEM LOCKED UP AND CONTINUED TO X-RAY PRIOR TO A CASE. THE SYSTEM HAD TO BE REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER SYSTEM. THERE WAS NO 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 |