FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1961172
·
Received January 11, 2011
Report
- Report Number
- 1720753-2011-00159
- Event Type
- Malfunction
- Date Received
- January 11, 2011
- Date of Event
- December 16, 2010
- Report Date
- January 11, 2011
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE 3 VOLT BATTERY ON X-RAY CONTROLLER BOARD WAS REPLACED. THE GENERATOR GROUND CABLE CONNECTION WAS REPAIRED. THE GENERATOR BOARD WAS RESEATED AND THE BATTERY REPLACED DURING THE SERVICE CALL. 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 THE KILO VOLTS WOULD SPIKE ON THE FIRST USE THEN THERE WAS NO IMAGE ON THE SCREEN ON THE 9800 SYSTEM. NO PT INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |