BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20E

    MDR report key: 4140848 · Received October 3, 2014

    Report

    Report Number
    2936999-2014-00871
    Event Type
    Malfunction
    Date Received
    October 3, 2014
    Date of Event
    September 19, 2014
    Report Date
    September 19, 2014
    Manufacturer
    COVIDIEN/FORMERLY TYCO HEALTHCARE
    Product Code
    DQA
    PMA / PMN Number
    K915699
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT THIS N20 PORTABLE PULSE OXIMETER IS MISSING DISPLAY SEGMENTS. THE PATIENT WAS NOT HARMED OR INJURED AS A RESULT OF THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    620708 NELLCOR N20E PORTABLE PULSE OXIMETER DQA COVIDIEN/FORMERLY TYCO HEALTHCARE N20-E

    Patients

    Seq Age Sex Outcome Treatment
    1