BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20

    MDR report key: 2770144 · Received October 1, 2012

    Report

    Report Number
    2936999-2012-00447
    Event Type
    Malfunction
    Date Received
    October 1, 2012
    Date of Event
    July 1, 2012
    Report Date
    July 17, 2012
    Manufacturer
    COVIDIEN, FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K915699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT DISPLAY SEGMENTS ARE MISSING. THE SERIAL NUMBER LABEL ON THE UNIT IS MISSING. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1