FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2152903
·
Received June 17, 2011
Report
- Report Number
- 1720753-2011-08283
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 20, 2011
- Report Date
- June 17, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SVC REP PERFORMED AN ONSITE INVESTIGATION. THE SVC REP REPLACED THE GENERAL PURPOSE OPERATING SYSTEM AND ADJUSTED THE 5VDC VOLTAGE AT THE FLUORO FUNCTIONS BOARD, AND RESEATED THE CONNECTOR ON THE POWER SUPPLY, AND THE FUSE AT THE POWER DISTRIBUTION BOARD. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SVC.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM'S TOUCH SCREEN WOULD NOT WORK PROPERLY. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |