BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 4274839 · Received November 24, 2014

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    Report

    Report Number
    2936999-2014-00970
    Event Type
    Malfunction
    Date Received
    November 24, 2014
    Date of Event
    October 27, 2014
    Report Date
    October 27, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Description of Event or Problem · 1

    COVIDIEN RECIEVED A REPORT OF A N560 WHERE THE FAR LEFT SEGMENT ON THE DISPLAY WAS INTERMITENTLY NOT DISPLAYED.THIS LOCATION IS ON THE SATURATION READINGS PORTION OF THE DEVICE. NO PATIENT HARM WAS REPORTED TO COVIDIEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760002 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1