BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9800

    MDR report key: 4912116 · Received July 10, 2015

    Report

    Report Number
    1720753-2015-02788
    Event Type
    Malfunction
    Date Received
    July 10, 2015
    Date of Event
    May 22, 2015
    Report Date
    July 10, 2015
    Manufacturer
    GE OEC MEDICAL SYSTEMS
    Product Code
    JAA
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE SERVICE REPRESENTATIVE PERFORMED AN ONSITE INVESTIGATION. THE INTERCONNECT CABLE, WAS EVALUATED AND REPLACED. THE 5 VDC POWER SUPPLY WAS ALSO EVALUATED AND CALIBRATED TO THE OPTIMAL OPERATING VOLTAGE. THE SYSTEM WAS TESTED AND FOUND TO BE WORKING AS INTENDED AND RETURNED TO SERVICE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE SYSTEM EXPERIENCED AN ERROR AND LOCKED UP. NO PATIENT SERIOUS INJURY OR DEATH WAS REPORTED RELATED TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    448735 9800 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS 9800 82-3823

    Patients

    Seq Age Sex Outcome Treatment
    1