BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3964596 · Received May 30, 2014

    Report

    Report Number
    2936999-2014-00432
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 8, 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). COVIDIEN SERVICE CENTER VERIFIED AND 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 RECEIVED A REPORT OF A N560 FOR A MISSING SEGMENT OF THE DISPLAY. THE FAILURE HAPPENED WHEN THE N560 WAS NOT BEING USED ON A PATIENT, THE TECHNICIAN WAS CHECKING THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318179 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1