BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VOLARA NEBULIZER MACHINE

    MDR report key: 12720629 · Received October 29, 2021

    Report

    Report Number
    MW5105026
    Event Type
    Malfunction
    Date Received
    October 29, 2021
    Date of Event
    October 21, 2021
    Report Date
    October 28, 2021
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021, AT APPROXIMATELY 03:20PM, THE FIRE ALARM WAS ACTIVATED FOR THE SICU DUE TO A MEDICAL DEVICE (VOLARA NEBULIZER SYSTEM) THAT CAUGHT ON FIRE AFTER A "POP" SOUND WAS HEARD. THE DEVICE WAS BEING STORED IN A CLEAN UTILITY ROOM AND A BIOMEDICAL TECHNICIAN WAS IN THE CLEAN UTILITY ROOM AT THE TIME OF THE DEVICE FAILURE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1621991 VOLARA NEBULIZER MACHINE DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ HILL-ROM MANUFACTURING, INC. PVL 1

    Patients

    Seq Age Sex Outcome Treatment
    1