FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 2041490
·
Received March 24, 2011
Report
- Report Number
- 1720753-2011-02731
- Event Type
- Malfunction
- Date Received
- March 24, 2011
- Date of Event
- March 16, 2011
- Report Date
- March 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MANUFACTURER'S SERVICE REPRESENTATIVE PERFORMED AN ON-SITE INVESTIGATION. THE SERVICE REPRESENTATIVE SEPARATED THE OUTER METAL CASING OF THE PEDAL. THE SYSTEM WAS TESTED AND IS OPERATING AS INTENDED. THIS EVENT MAY HAVE RESULTED IN AN ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE FOOTSWITCH ON THE 6800 SYSTEM WOULD STICK AND NOT SHUT OFF AFTER RELEASE. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |