FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 1992836
·
Received February 4, 2011
Report
- Report Number
- 9680959-2011-00270
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- September 21, 2010
- Report Date
- February 4, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS GMBH
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE IMAGE PROCESSOR COMPUTER WAS REPLACED AND THE SOFTWARE WAS UPDATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM FAILED TO BOOT UP. NO REPORT OF PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 7900 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS GMBH | 7900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |