FDA Adverse Event
Malfunction
Summary report: N
7900
MDR report key: 2090501
·
Received April 26, 2011
Report
- Report Number
- 9680959-2011-01114
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- April 1, 2011
- Report Date
- April 26, 2011
- 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
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SYSTEM SOFTWARE WAS RELOADED AND THE IMAGE PROCESSING COMPUTER WAS RECONFIGURED. THE LASER COVER NEEDS TO BE REPLACED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 7900 SYSTEM WOULD NOT CALIBRATE CORRECTLY AFTER BOOTING UP. NO PATIENT INJURY WAS REPORTED.
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 |