BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20

    MDR report key: 3123999 · Received May 15, 2013

    Report

    Report Number
    8020893-2013-01069
    Event Type
    Malfunction
    Date Received
    May 15, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN THAT THE UNIT'S DISPLAY WAS MISSING SEGMENTS. NO PT INVOLVEMENT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214979 NELLCOR N20 PORTABLE PULSE OXIMETER DQA COVIDIEN/FORMERLY TYCO HEALTHCARE N-20

    Patients

    Seq Age Sex Outcome Treatment
    1