FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1892934
·
Received November 2, 2010
Report
- Report Number
- 1720753-2010-03839
- Event Type
- Malfunction
- Date Received
- November 2, 2010
- Date of Event
- October 13, 2010
- Report Date
- November 2, 2010
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ON SITE INVESTIGATION. THE X-RAY TUBE WAS REPLACED AND THE GENERATOR CALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE SYSTEM'S IMAGES DISAPPEARED AND POPPING COULD BE HEARD. NO REPORT OF PT INJURY.
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 |