FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2021896
·
Received February 25, 2011
Report
- Report Number
- 1720753-2011-01692
- Event Type
- Malfunction
- Date Received
- February 25, 2011
- Date of Event
- January 10, 2011
- Report Date
- February 25, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE GE REP PERFORMED AN ON SITE INVESTIGATION. THE HIGH VOLTAGE CABLE WAS REPLACED AND THE INSULATED GATE BIPOLAR TRANSISTOR WAS REPLACED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED, THE SYSTEM WAS NOT DISPLAYING IMAGES AND THE SYSTEM APPEARED TO BE FAILING TO FLUOROSCOPY XRAY. THERE WAS NO REPORT OF PT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC XRAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |