BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3884269 · Received May 20, 2014

    Report

    Report Number
    1720753-2014-04320
    Event Type
    Malfunction
    Date Received
    May 20, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 20, 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 REP PERFORMED AN ONSITE INVESTIGATION. THE REPORTED ISSUE COULD NOT BE DUPLICATED. THE SYSTEM SOFTWARE AND CALIBRATIONS WERE RELOADED BY THE INHOUSE BIOMED TECHNICIAN. THE INTERCONNECT CABLE WAS ALSO EVALUATED AND IDENTIFIED AS REQUIRING REPLACEMENT. THE CABLE WAS ORDERED FOR REPLACEMENT BY THE CUSTOMER. NO CONCLUSION CAN BE DRAWN AS CONCLUSIVE REPAIR INFO IS UNAVAILABLE AT THIS TIME AND NO ADD'L SVC INFO WAS PROVIDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM FAILED TO PROPERLY SAVE AND RECALL PT IMAGE DATA. NO PT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    298934 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1