FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2192876
·
Received July 25, 2011
Report
- Report Number
- 1720753-2011-20349
- Event Type
- Malfunction
- Date Received
- July 25, 2011
- Date of Event
- July 12, 2011
- Report Date
- July 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. 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 A BAD IRIS POTENTIOMETER ERROR MESSAGE DISPLAYED UPON BOOT UP AND THEN DISAPPEARED. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |