FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2191474
·
Received July 27, 2011
Report
- Report Number
- 1720753-2011-20459
- Event Type
- Malfunction
- Date Received
- July 27, 2011
- Date of Event
- July 21, 2011
- Report Date
- July 27, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE COLLIMATOR WAS REPLACED, BUT THE PHENOMENON RECURRED. THE REP WILL OBTAIN PARTS AND TROUBLESHOOT AGAIN. NO CONCLUSION CAN BE DRAWN AS FURTHER REPAIR INFO IS UNAVAILABLE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE COLLIMATOR IRIS POTENTIOMETER ERROR-PRESS ANY KEY OCCURRED. THE SYSTEM COULD STILL RADIOGRAPH BY PRESSING THE BUTTON. 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 |