BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3846972 · Received March 13, 2014

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    Report

    Report Number
    2936999-2014-00250
    Event Type
    Malfunction
    Date Received
    March 13, 2014
    Date of Event
    December 27, 2013
    Report Date
    March 6, 2014
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DPZ
    PMA / PMN Number
    K012891
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). COVIDIEN SERVICE CENTER REPLACED THE FRONT PRINTED CIRCUIT BOARD (PCB) AND RETURNED UNIT TO CUSTOMER. INFO OF THIS NATURE IS INCLUDED IN OUR DATABASE AND MONITORED THROUGH TRENDING.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT THE N-560 UNIT WAS MISSING DISPLAY SEGMENTS. THERE WAS NO PT INVOLVEMENT WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    151196 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DPZ NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1