BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    9900

    MDR report key: 2021657 · Received February 21, 2011

    Report

    Report Number
    1720753-2011-01537
    Event Type
    Malfunction
    Date Received
    February 21, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 21, 2011
    Manufacturer
    GE OEC MEDICAL SYSTEMS (SLC)
    Product Code
    JAA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE SYSTEM AND REPLACED THE RTOS SINGLEBOARD COMPUTER. THE SYSTEM OPERATES AS INTENDED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED, THE SYSTEM DISPLAYED A "INVALID INPUT SIGNAL" ERROR MESSAGE AND WOULD NOT COMPLETE BOOT UP. NO PATIENT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 9900 FLUOROSCOPIC X-RAY JAA GE OEC MEDICAL SYSTEMS (SLC) 9900

    Patients

    Seq Age Sex Outcome Treatment
    1