BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20

    MDR report key: 4092568 · Received August 19, 2014

    Report

    Report Number
    2936999-2014-00769
    Event Type
    Malfunction
    Date Received
    August 19, 2014
    Date of Event
    August 1, 2014
    Report Date
    August 7, 2014
    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
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER DID NOT PROVIDE THE SERIAL NUMBER. NO MANUFACTURER DATE CAN BE DETERMINED (B)(4).

    Description of Event or Problem · 1

    COVIDIEN RECEIVED INFORMATION THAT THIS N20 PORTABLE PULSE OXIMETER IS MISSING DISPLAY SEGMENTS IN THE SATURATION OF PERIPHERAL OXYGEN (SPO2) READINGS. THE FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500087 NELLCOR N20 PORTABLE PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-20

    Patients

    Seq Age Sex Outcome Treatment
    1