BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3807196 · Received March 21, 2014

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    Report

    Report Number
    2936999-2014-00252
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 21, 2014
    Report Date
    February 21, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KN
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE PULSE AND SPO2 WERE NOT PROPERLY DISPLAYED. THE SEGMENTS WERE NOT LIT. THE FRONT BOARD WAS REPLACED AND THE UNIT IS WORKING WELL. THERE WAS NO PATIENT INVOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169200 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1