BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3888086 · Received April 15, 2014

    Report

    Report Number
    2936999-2014-00344
    Event Type
    Malfunction
    Date Received
    April 15, 2014
    Date of Event
    March 20, 2014
    Report Date
    April 2, 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 VERIFIED AN INTERMITTENT FAILURE OF THE FRONT PCB AND MAIN PCB BOARDS, THESE PCB BOARDS WERE REPLACED AND THE UNIT PASSED TESTS.

    Description of Event or Problem · 1

    A N-560 WAS RETURNED TO A COVIDIEN SERVICE CENTER WITH A REPORT OF A DISPLAY ERROR. ON (B)(6) 2014, UPON INVESTIGATION, COVIDIEN DETERMINED THAT THE DISPLAY WAS INTERMITTENTLY MISSING SEGMENTS. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231532 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1