FDA Adverse Event
Malfunction
Summary report: N
9600
MDR report key: 2241214
·
Received August 18, 2011
Report
- Report Number
- 1720753-2011-21150
- Event Type
- Malfunction
- Date Received
- August 18, 2011
- Date of Event
- August 9, 2011
- Report Date
- August 18, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE SERVICE REP CLEANED AND REGREASED THE HIGH VOLTAGE CABLE ENDS. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK IN SERVICE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM WOULD DISPLAY A CHARGER FULL ERROR MESSAGE AND SHUTDOWN DURING A PROCEDURE. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9600 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 960 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |