BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3826338 · Received February 25, 2014

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    Report

    Report Number
    2936999-2014-00175
    Event Type
    Malfunction
    Date Received
    February 25, 2014
    Date of Event
    January 23, 2014
    Report Date
    January 28, 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

    THE FRONT BOARD WAS REPLACED. THE MFR DATE IS UNK WITH THE SERIAL NUMBER PROVIDED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT WAS RETURNED FOR REPAIR FOR MISSING SEGMENT IN DISPLAY. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116105 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1