BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20E

    MDR report key: 2971987 · Received February 18, 2013

    Report

    Report Number
    2936999-2013-00096
    Event Type
    Malfunction
    Date Received
    February 18, 2013
    Date of Event
    January 22, 2013
    Report Date
    January 22, 2013
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K952222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, 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. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71316 NELLCOR N20E PORTABLE PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-20E

    Patients

    Seq Age Sex Outcome Treatment
    1