FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 1941129
·
Received December 22, 2010
Report
- Report Number
- 1720753-2010-04879
- Event Type
- Malfunction
- Date Received
- December 22, 2010
- Date of Event
- December 7, 2010
- Report Date
- December 22, 2010
- 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 REPRESENTATIVE PERFORMED AN ON SITE INVESTIGATION. THE CASTER AND X-RAY TUBE WERE REPLACED AND THE HIGH VOLTAGE CABLE WAS CLEANED AND REGREASED 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 9800 SYSTEM MADE A LOUD ARCHING SOUND THEN HAD NO IMAGE DURING A CASE. ALSO THE WORKSTATION WAS HARD TO STEER. NO PATIENT 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 |