FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2031266
·
Received March 16, 2011
Report
- Report Number
- 1720753-2011-02383
- Event Type
- Malfunction
- Date Received
- March 16, 2011
- Date of Event
- February 23, 2011
- Report Date
- March 16, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. CONNECTIONS ON THE POWER SUPPLY ONE, THE POWER SIGNAL INTERFACE BOARD, AND THE BOARDS IN THE MAINFRAME CARD RACK WERE RESEATED. THE POWER SUPPLY WAS ADJUSTED. THE SYSTEM WAS TESTED AND OPERATES AS INTENDED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD FREEZE UP AND WOULD NOT PRODUCE X-RAYS OR PROGRESS BEYOND THE WARM UP STAGE. 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 |