BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NELLCOR N20PA

    MDR report key: 4092542 · Received August 19, 2014

    Report

    Report Number
    2936999-2014-00770
    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
    K952222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    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 FAILURE HAPPENED WHEN THE DEVICE WAS NOT BEING USED ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    500196 NELLCOR N20PA PORTABLE PULSE OXIMETER DQA COVIDIEN, FORMERLY TYCO HEALTHCARE N-20PA

    Patients

    Seq Age Sex Outcome Treatment
    1