BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20E

    MDR report key: 2860172 · Received November 21, 2012

    Report

    Report Number
    2936999-2012-00608
    Event Type
    Malfunction
    Date Received
    November 21, 2012
    Date of Event
    October 1, 2012
    Report Date
    October 23, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEATLHCARE
    Product Code
    DQA
    PMA / PMN Number
    K952222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT WAS MISSING DISPLAY SEGMENTS. THERE WAS NO PATIENT HARM REPORTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1