BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CCDS CRITICAL CARE DECONTAMINATION SYSTEM

    MDR report key: 10796427 · Received November 5, 2020

    Report

    Report Number
    1523658-2020-00147
    Event Type
    Malfunction
    Date Received
    November 5, 2020
    Date of Event
    July 31, 2020
    Report Date
    November 5, 2020
    Manufacturer
    BATTELLE MEMORIAL INSTITUTE
    Product Code
    QKY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT RETURNED. CCDS STAFF HAVE DISCUSSED THE MASK SCREENING PROCESS AND REMINDED THE HCP TO ALSO VISUALLY INSPECT AND NOT SEND FOR DECON, AS WELL NOTED THAT BATTELLE IS NOT THE SOURCE OF THE MAKE-UP.

    Description of Event or Problem · 1

    USER REPORTED MAKEUP ON THE INSIDE OF THE MASKS AND THE SEAMS ON THE OUTSIDE. THE MASKS ASSOCIATED WITH THIS EVENT WERE DECONTAMINATED WITH THE BATTELLE CCDS "CLOSED SYSTEM" PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257042 CCDS CRITICAL CARE DECONTAMINATION SYSTEM DECONTAMINATION SYSTEM FOR RESPIRATORS QKY BATTELLE MEMORIAL INSTITUTE

    Patients

    Seq Age Sex Outcome Treatment
    1