BEUDAMED
    FDA Adverse Event Malfunction Summary report: Y

    DUKE HEALTH EUA 200335

    MDR report key: 10754539 · Received October 29, 2020

    Report

    Report Number
    3017487795-2020-00002
    Event Type
    Malfunction
    Date Received
    October 29, 2020
    Date of Event
    September 1, 2020
    Report Date
    October 27, 2020
    Manufacturer
    DUKE UNIVERSITY HEALTH SYSTEM
    Product Code
    QKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RECEIVED THE FOLLOWING IN AN EMAIL, "FOR YOUR AWARENESS AND IN CASE THIS BECOMES A TREND - TWO REPROCESSED N95 STRAPS BROKE ON 8200 WHILE THE CAREGIVERS WERE IN THE ROOM". N95 MASKS WERE DISCARDED AND SUBSEQUENT FOLLOW-UP DETERMINED THE EVENTS WERE ANECDOTAL.

    Description of Event or Problem · 1

    RECEIVED THE FOLLOWING IN AN EMAIL, "FOR YOUR AWARENESS AND IN CASE THIS BECOMES A TREND - TWO REPROCESSED N95 STRAPS BROKE ON 8200 WHILE THE CAREGIVERS WERE IN THE ROOM". N95 MASKS WERE DISCARDED AND SUBSEQUENT FOLLOW-UP DETERMINED THE EVENTS WERE ANECDOTAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224613 DUKE HEALTH EUA 200335 DUKE DECONTAMINATION SYSTEM QKY DUKE UNIVERSITY HEALTH SYSTEM

    Patients

    Seq Age Sex Outcome Treatment
    1