BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    N600X PULSE OXIMETER

    MDR report key: 3180073 · Received June 13, 2013

    Report

    Report Number
    2936999-2013-00431
    Event Type
    Malfunction
    Date Received
    June 13, 2013
    Date of Event
    May 1, 2013
    Report Date
    May 15, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO
    Product Code
    DQA
    PMA / PMN Number
    K060576
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATED UNIT IS GIVING LOW READINGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269510 N600X PULSE OXIMETER PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO

    Patients

    Seq Age Sex Outcome Treatment
    1