BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OXIMAX N-560 PULSE OXIMETER

    MDR report key: 4132519 · Received October 1, 2014

    Report

    Report Number
    2936999-2014-00862
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    MEDIANA
    Product Code
    DQA
    PMA / PMN Number
    K012891
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HOSPITAL SERVICE TECHNICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    COVIDIEN INVESTIGATION VERIFIED THE LOW SATURATION READINGS AND THE FAILURE WAS ISOLATED TO THE SPO2 PCB.

    Description of Event or Problem · 1

    COVIDIEN RECEIVED A REPORT OF A N560 THAT WOULD NOT WORK OPTIMALLY DUE TO LOW SATURATION READINGS. NO PATIENT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610526 OXIMAX N-560 PULSE OXIMETER PULSE OXIMETER DQA MEDIANA N-560

    Patients

    Seq Age Sex Outcome Treatment
    1