BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3963285 · Received June 18, 2014

    Report

    Report Number
    2936999-2014-00523
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 1, 2014
    Report Date
    May 26, 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

    COVIDIEN TECHNICIAN VERIFIED THE MISSING SEGMENTS. THE MAIN BOARD AND THE DISPLAY PCB WERE REPLACED. (B)(4). THE SERIAL NUMBER OF THE DISPLAY PCB PRECEDES A CORRECTIVE AND PREVENTIVE ACTION TAKEN BY THE MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT SPORADICALLY SOME SEGMENTS ARE MISSING IN THE DISPLAY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356688 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1