FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 3960448
·
Received June 9, 2014
Report
- Report Number
- 1720753-2014-04843
- Event Type
- Malfunction
- Date Received
- June 9, 2014
- Date of Event
- May 20, 2014
- Report Date
- June 9, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REP PERFORMED AN ONSITE INVESTIGATION. THE HV (HIGH VOLTAGE) CABLE WAS EVALUATED AND REPLACED. A FULL FILAMENT CALIBRATION WAS ALSO PERFORMED. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THE SYSTEM EXHIBITED FILAMENT REGULATOR FAILURE ERRORS DURING A PT PROCEDURE. THIS EVENT MAY HAVE RESULTED IN AN ARO (ACCIDENTAL RADIATION OCCURRENCE). NO PT DEATH OR SERIOUS INJURY WAS REPORTED RELATED TO THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 335070 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |