FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2152932
·
Received June 17, 2011
Report
- Report Number
- 1720753-2011-08266
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- June 6, 2011
- Report Date
- June 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 X3 LINE ON THE IMAGE INTENSIFIER WAS RESEATED AND THE CAMERA WAS REPLACED. THE ENTRANCE DOSE WAS ADJUSTED AND THE CAMERA AND COLLIMATOR STOPS WERE ADJUSTED. 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 DISPLAYED INTERMITTENT BLURRY IMAGES. NO PATIENT 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 |