BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMETER N-560 PULSE OXIMETER

    MDR report key: 3963284 · Received June 18, 2014

    Report

    Report Number
    2936999-2014-00525
    Event Type
    Malfunction
    Date Received
    June 18, 2014
    Date of Event
    May 1, 2014
    Report Date
    June 12, 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 SERVICE CTR REPLACED THE FRONT PCB AND MAIN BOARD. (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 THE UNIT HAD A BLANK DISPLAY. COVIDIEN TECHNICIAN FOUND THAT THE UNIT HAD SEGMENTS MISSING IN THE DISPLAY. THERE WAS NO PT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356902 OXIMETER N-560 PULSE OXIMETER PULSE OXIMETER DPZ MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1