BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20

    MDR report key: 3032698 · Received March 29, 2013

    Report

    Report Number
    2936999-2013-00207
    Event Type
    Malfunction
    Date Received
    March 29, 2013
    Date of Event
    March 12, 2013
    Report Date
    March 12, 2013
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K915699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ON THE BOTTOM FAR LEFT WINDOW OF THE BPM SIDE. NO PT HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    130672 NELLCOR N20 PORTABLE PULSE GENERATOR DQA COVIDIEN/FORMERLY TYCO HEALTHCARE N-20

    Patients

    Seq Age Sex Outcome Treatment
    1