FDA Adverse Event
Other
Summary report: N
GE OEC 9800
MDR report key: 906971
·
Received August 29, 2007
Report
- Report Number
- 1720753-2007-04961
- Event Type
- Other
- Date Received
- August 29, 2007
- Date of Event
- August 9, 2007
- Report Date
- August 29, 2007
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IN, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE OEC SERVICE REPRESENTATIVE INVESTIGATED THE ISSUE AND FOUND A MISSING SECONDARY COLLIMATOR FILTER, THAT WAS INSTALLED AND ALIGNED. THE SYSTEM WAS TESTED, FOUND TO BE OPERATING AS INTENDED, AND RELEASED OT THE CUSTOMER FOR USE. THE FACILITY WAS UNABLE TO, OR WOULD NOT PROVIDE ANY PT INFORMATION WITH RESPECT TO THIS ISSUE. NO PT INJURY OR HARM WAS REPORTED AS A RESULT OF THE NOTED MALFUNCTION.
Description of Event or Problem · 1
THE GE OEC 9800 FLUOROSCOPY SYSTEM WAS MISSING THE SECONDARY COLLIMATOR FILTER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GE OEC 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | 9800 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR |