FDA Adverse Event
Malfunction
Summary report: N
7700
MDR report key: 2040698
·
Received March 22, 2011
Report
- Report Number
- 9680959-2011-00815
- Event Type
- Malfunction
- Date Received
- March 22, 2011
- Date of Event
- February 22, 2011
- Report Date
- March 22, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE ASSEMBLY, GENERATOR, AND COLLIMATOR WERE REPLACED. ALSO, THE VOLTAGE WAS CHECKED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEMS' THERMOMETER DISPLAYED AN OVER HEATING OF THE UNIT. ALSO, THE LIFT COLUMN WAS INOPERABLE. NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7700 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |