FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2241145
·
Received August 17, 2011
Report
- Report Number
- 1720753-2011-21119
- Event Type
- Malfunction
- Date Received
- August 17, 2011
- Date of Event
- August 10, 2011
- Report Date
- August 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OR, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. FLUOROSCOPIC X-RAY WAS PERFORMED WITH NO ISSUES AND THE LINE CONNECTIONS ON THE CORD AND THE TRANSFORMER WERE CHECKED AND HAD NO ISSUES. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD NOT DISPLAY ANY IMAGES AND PT DATA WAS GONE. 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 |