BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2960944 · Received January 30, 2013

    Report

    Report Number
    1720753-2013-01196
    Event Type
    Malfunction
    Date Received
    January 30, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 30, 2013
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REP PERFORMED ONSITE INVESTIGATION. THE POWER SUPPLY VOLTAGE WAS ADJUSTED, THE HIGH VOLTAGE CONNECTORS WERE REGREASED AND THE GENERATOR AND FILAMENT WERE RECALIBRATED. THE SYSTEM WAS THEN FOUND TO BE OPERATING AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHEN THE FOOT PEDAL WAS DEPRESSED, AN ALERT TONE AND BEEP WOULD COME FROM THE SYSTEM AND THE SYSTEM WOULD LOCK UP. THERE IS NO REPORT OF PT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40151 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1