BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTIDIAGNOST ELEVA

    MDR report key: 2182557 · Received July 5, 2011

    Report

    Report Number
    3003768277-2011-00428
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Report Date
    June 10, 2011
    Manufacturer
    PHILIPS HEALTHCARE
    Product Code
    IZI
    PMA / PMN Number
    K050151
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AFTER INVESTIGATION IT TURNED OUT THAT A CABLE WAS PULLED FROM THE CONTROLLER CONSOLE AND THE CABLE LOCK WAS BROKEN OFF. THE FIELD SERVICE ENGINEER (FSE) REPLACED THE KEYBOARD CABLE, EXTERN AND TESTED THE SYSTEM. THE SYSTEM HAS BEEN REPORTED TO BE WORKING ACCORDING TO SPECIFICATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS NO EXPOSURE DURING CASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTIDIAGNOST ELEVA IZI, KPR IZI PHILIPS HEALTHCARE 708037

    Patients

    Seq Age Sex Outcome Treatment
    1