BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20PA

    MDR report key: 2971982 · Received February 18, 2013

    Report

    Report Number
    2936999-2013-00093
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    January 21, 2013
    Report Date
    January 21, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K952222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT'S DISPLAY WAS MISSING SEGMENTS, THE BOTTOM SEGMENTS IN THE FAR LEFT WINDOW. NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    70931 NELLCOR N20PA PORTABLE PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-20PA

    Patients

    Seq Age Sex Outcome Treatment
    1