FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2023065
·
Received February 24, 2011
Report
- Report Number
- 1720753-2011-01615
- Event Type
- Malfunction
- Date Received
- February 24, 2011
- Date of Event
- January 25, 2011
- Report Date
- February 24, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE MFR'S SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE ENGINEER COULD NOT DUPLICATE OR IDENTIFY THE REPORTED ISSUE; HOWEVER, PERFORMED A SUCCESSFUL FORMAT OF THE WORKSTATION HARD DRIVE. THE SYSTEM WAS TESTED AND OPERATED AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTS THE 9800 SYSTEM HAS JOYSTICK ISSUES, THE LEFT MONITOR CHANGES BRIGHTNESS AND THE PT INFO FROM ONE STUDY IS GOING INTO OTHER STUDIES. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |