BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 3190078 · Received June 18, 2013

    Report

    Report Number
    1720753-2013-07326
    Event Type
    Malfunction
    Date Received
    June 18, 2013
    Date of Event
    June 13, 2013
    Report Date
    June 19, 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 REPRESENTATIVE EVALUATED THE SYSTEM AND ADJUSTED THE 5 VOLT POWER SUPPLY, AND REPLACED THE GENERATOR INTERFACE BOARD. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SYSTEM DISPLAYED A COMMUNICATION ERROR. THIS ERROR WILL CAUSE THE SYSTEM TO LOCKUP, SHUT DOWN, OR NOT TO BOOT. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    275969 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1