FDA Adverse Event
Malfunction
Summary report: N
9800
MDR report key: 2982104
·
Received February 8, 2013
Report
- Report Number
- 1720753-2013-01593
- Event Type
- Malfunction
- Date Received
- February 8, 2013
- Date of Event
- January 18, 2013
- Report Date
- February 8, 2013
- 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 ON SITE INVESTIGATION. THE SYSTEM WAS RESET DURING THE SERVICE CALL. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND PUT BACK ITO SERVICE. THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ACCIDENTAL RADIATION OCCURRENCE.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THAT THERE WAS A COLLIMATOR IRIS POT ERROR THAT OCCURRED DURING A PROCEDURE WITH PT INVOLVEMENT, THEREFORE, THIS MALFUNCTION MAY HAVE RESULTED IN A POSSIBLE ARO. THERE IS NO REPORT OF INJURY OR DEATH ASSOCIATED WITH THE EVENT DESCRIBED IN THIS COMPLAINT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 55179 | 9800 | FLUOROSCOPIC X-RAY | JAA | GE OEC MEDICAL SYSTEMS (SLC) | 9800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |