BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20

    MDR report key: 2770141 · Received October 1, 2012

    Report

    Report Number
    2936999-2012-00441
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    June 1, 2012
    Report Date
    June 14, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HE...
    Product Code
    DQA
    PMA / PMN Number
    K915699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE DEVICE WAS CHECKED AND THERE ARE MISSING SEGMENTS IN THE DISPLAY. THERE WAS NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NELLCOR N20 PORTABLE PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HE... N-20

    Patients

    Seq Age Sex Outcome Treatment
    1