FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2191200
·
Received July 19, 2011
Report
- Report Number
- 1720753-2011-20205
- Event Type
- Malfunction
- Date Received
- July 19, 2011
- Date of Event
- July 5, 2011
- Report Date
- July 19, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SERVICE REPRESENTATIVE DETERMINED THE PROBLEM WAS CAUSED BY TOE TAPPING. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A CHARGER FAILED, AND SECURITY SWITCH ERROR MESSAGES'. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |