FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1232562
·
Received November 13, 2008
Report
- Report Number
- 1720753-2008-27990
- Event Type
- Malfunction
- Date Received
- November 13, 2008
- Date of Event
- October 23, 2008
- Report Date
- November 12, 2008
- Manufacturer
- GE OEC MEDICAL SYSTEMS INC.
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THIS MDR IS RELATED TO GE HEALTHCARE COMPLAINT NUMBER. THE GE SERVICE REP ORDERED PARTS AND REPLACED THE CONTROL PANEL PROCESSOR PCBS IN THE MAINFRAME. HE ADJUSTED THE 5VDC FROM 4.79V TO 5.05VDC AND ORDERED THE REPLACEMENT FOOTSWITCH TO REPLACE. THE FOOTSWITCH WAS THEN REPLACED. THE SYSTEM OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT WHEN OPERATING, THE MACHINE STOPS FLUOROING AND THE SCREENS GO BLACK. ALSO, THEY WERE GETTING A CONTROL PANEL ERROR AND THE KEY WAS STUCK. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |