BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3807195 · Received March 21, 2014

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    Report

    Report Number
    2936999-2014-00270
    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
    UK
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE FAULTY DISPLAY WAS CONFIRMED. THE FRONT PANEL WAS REPLACED. (B)(4). SERIAL NUMBER OF THE FRONT PCB PRECEDES A CORRECTIVE AND PREVENTATIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN OF A FAULTY DISPLAY, THE SEGMENTS ON DISPLAY ARE NOT ILLUMINATING. SOME OF THE SEGMENTS ARE BLANK. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169199 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1