FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2062334
·
Received April 12, 2011
Report
- Report Number
- 1720753-2011-03533
- Event Type
- Malfunction
- Date Received
- April 12, 2011
- Date of Event
- March 25, 2011
- Report Date
- April 12, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE VERIFIED THE RADIATION DOSE TO BE WITHIN THE NORMAL LIMITATIONS. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED. THIS EVENT MAY BE AN ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE 9800 SYSTEM WOULD SEEM TO EXPOSE FLUORO TWICE WHEN THE SWITCH WAS PRESSED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |