FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2022252
·
Received February 28, 2011
Report
- Report Number
- 1720753-2011-01711
- Event Type
- Malfunction
- Date Received
- February 28, 2011
- Date of Event
- February 1, 2011
- Report Date
- February 28, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION AND PERFORMED STOP CALIBRATION TESTS. THE PROBLEM COULD NOT BE DUPLICATED. THE SYSTEM WAS FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE 9800 SYSTEM DISPLAYED STUCK COLLIMATOR ERROR. NO PATIENT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPY X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |