BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-600 PULSE OXIMETER

    MDR report key: 2918463 · Received January 10, 2013

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    Report

    Report Number
    2936999-2013-00031
    Event Type
    Malfunction
    Date Received
    January 10, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCOHEAL
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    CALLER STATES HE NOTICED TODAY THAT THERE WAS NO BEEP ON POWER UP AND NO AUDIO WITH AN ALARM. CALLER STATES THERE IS NO PT INVOLVEMENT AS SHE GOT THIS UNIT FOR PREVENTATIVE MAINTENANCE AND CHARGED OVER THE WEEKEND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15130 OXIMAX N-600 PULSE OXIMETER PULSE OXIMETER DPZ COVIDIEN, FORMERLY TYCOHEAL

    Patients

    Seq Age Sex Outcome Treatment
    1