BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3901649 · Received May 5, 2014

    Report

    Report Number
    2936999-2014-00397
    Event Type
    Malfunction
    Date Received
    May 5, 2014
    Date of Event
    January 13, 2014
    Report Date
    April 7, 2014
    Manufacturer
    MEDIANA
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE FAULT WAS FOUND WITH THE FRONT PCB BOARD, AND THE FRONT PCB BOARD WAS REPLACED. THE MANUFACTURE DATE OF THE PRODUCT PRECEDES A SUPPLIER CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER FOR THIS REPORTED FAILURE.

    Description of Event or Problem · 1

    COVIDIEN-(B)(4) SERVICE CENTER RECEIVED A REPORT OF AN N-560 THAT COULD NOT DISPLAY THE SEGMENTS OF THE SATURATION VALUE. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268111 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1