BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8800

    MDR report key: 2935254 · Received January 14, 2013

    Report

    Report Number
    1720753-2013-00623
    Event Type
    Malfunction
    Date Received
    January 14, 2013
    Date of Event
    January 3, 2013
    Report Date
    January 14, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFORMATION IS UNAVAILABLE. HOWEVER, NO REPORT OF PT OR STAFF INJURY WAS REPORTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED "CAN NOT EXPOSURE." THIS ISSUE MAY REFER TO A LOSS OF X-RAY FUNCTIONALITY. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21492 8800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 8800

    Patients

    Seq Age Sex Outcome Treatment
    1