BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6600

    MDR report key: 3161687 · Received June 3, 2013

    Report

    Report Number
    1720753-2013-06731
    Event Type
    Malfunction
    Date Received
    June 3, 2013
    Date of Event
    May 23, 2013
    Report Date
    June 4, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO CONCLUSION CAN BE DRAWN AS REPAIR INFO WAS NOT REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FLUORO PEDAL STUCK AND THE SYSTEM PRODUCED UNCOMMANDED X-RAYS. THERE IS NO REPORT OF PT INJURY OR DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243627 6600 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 6600

    Patients

    Seq Age Sex Outcome Treatment
    1