BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULUSE OXIMETER

    MDR report key: 3964595 · Received May 30, 2014

    Report

    Report Number
    2936999-2014-00459
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 15, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN EVALUATION ISOLATED THE FAILURE TO THE FRONT PCB BOARD. MANUFACTURING DATE OF THIS UNIT PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER FOR THIS FAILURE MODE.

    Description of Event or Problem · 1

    COVIDIEN SERVICE CENTER RECEIVED IN A N560 MONITOR AND DETERMINED THAT DISPLAY SEGMENTS WERE INTERMITTENTLY MISSING FROM THE HEART RATE SIDE OF THE MONITOR. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    317966 OXIMAX N-560 PULUSE OXIMETER PULSE OXIMETER DPZ MEDIANA N560

    Patients

    Seq Age Sex Outcome Treatment
    1