FDA Adverse Event
Malfunction
Summary report: N
9900
MDR report key: 3880263
·
Received April 8, 2014
Report
- Report Number
- 1720753-2014-03038
- Event Type
- Malfunction
- Date Received
- April 8, 2014
- Date of Event
- March 31, 2014
- Report Date
- April 8, 2014
- Manufacturer
- GE OEC MEDICAL SYSTEMS (SLC)
- Product Code
- JAA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE ANODE AND CATHODE LEADS ON X-RAY TUBE AND HIGH VOLTAGE TANK WERE EVALUATED AND REGREASED. 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 |
|---|---|---|---|---|---|---|---|
| 211919 | 9900 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |