FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 2172220
·
Received June 15, 2011
Report
- Report Number
- 1720753-2011-08225
- Event Type
- Malfunction
- Date Received
- June 15, 2011
- Date of Event
- June 1, 2011
- Report Date
- June 15, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE BUTTON COVER ON THE DOGHOUSE WAS RESNAPPED IN PLACE. THE VOLTAGE OUTPUT ON THE MAINFRAME AT PS1 WAS RAISED TO 5.15 VDC. THE INTERCONNECT CONNECTIONS AND THE WIRE CONNECTIONS ON THE WORKSTATION WERE CHECKED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT DURING A PROCEDURE THE SYSTEM DISPLAYED A COMMUNICATION FAILED ERROR MESSAGE AND HAD ISSUES WITH THE GENERATOR AND THE WORKSTATION. 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 |