FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2201147
·
Received July 29, 2011
Report
- Report Number
- 1720753-2011-20538
- Event Type
- Malfunction
- Date Received
- July 29, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 29, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REPRESENTATIVE REPOSITIONED A PIN IN THE FOOTSWITCH. THIS WAS NOT THE SAME FOOTSWITCH THAT WAS RECENTLY REPLACED. 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 HAD A SECURITY ERROR DURING A CASE. NO PATIENT 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 |