BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3888553 · Received April 30, 2014

    Report

    Report Number
    2936999-2014-00391
    Event Type
    Malfunction
    Date Received
    April 30, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 22, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CONDITION WAS VERIFIED BY COVIDIEN-(B)(6) SERVICE CENTER. THE FRONT PCB BOARD WAS REPLACED.

    Description of Event or Problem · 1

    RECEIVED A REPORT THAT THE N-560 IS MISSING SEGMENTS ON THE SATURATION PORTION OF THE DISPLAY. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258386 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1