FDA Adverse Event
Malfunction
Summary report: N
6800
MDR report key: 4251382
·
Received November 5, 2014
Report
- Report Number
- 1720753-2014-09173
- Event Type
- Malfunction
- Date Received
- November 5, 2014
- Date of Event
- October 15, 2014
- Report Date
- November 5, 2014
- 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 SERVICE REPRESENTATIVE PERFORMED AN OVER THE PHONE INVESTIGATION. THE CUSTOMER REPLACED POWER CABLE. THE SYSTEM WAS FOUND TO BE WORKING AS INTENDED. THE SYSTEM WAS PUT BACK INTO SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM INTERMITTENTLY DISPLAYED AN X-RAY COMMAND ERROR, THE FIELD ENGINEER NOTED THAT THE SYSTEM LOCKED UP BUT THE CUSTOMER WAS ABLE TO REBOOT. THERE IS NO REPORT OF DEATH OR SERIOUS INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 709973 | 6800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 6800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |