BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 3060930 · Received April 10, 2013

    Report

    Report Number
    2936999-2013-00281
    Event Type
    Malfunction
    Date Received
    April 10, 2013
    Date of Event
    March 13, 2013
    Report Date
    March 13, 2013
    Manufacturer
    NELLCOR PURITAN BENNETT
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    NO FAULT WAS FOUND DURING THE INVESTIGATION. UNIT IS OPERATIONAL, THERE WAS NO ALARM FAILURE.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE N-560 WAS NOT ALARMING WHEN SATURATION REGISTERED BELOW 85.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    153719 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA NELLCOR PURITAN BENNETT N-560

    Patients

    Seq Age Sex Outcome Treatment
    1