BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VOLARA

    MDR report key: 16324011 · Received February 7, 2023

    Report

    Report Number
    MW5114773
    Event Type
    Injury
    Date Received
    February 7, 2023
    Report Date
    February 3, 2023
    Manufacturer
    HILL-ROM MANUFACTURING, INC.
    Product Code
    NHJ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    VOLARA DEVICE UTILIZED FOR AIRWAY CLEARANCE THERAPY ON A PATIENT MECHANICALLY VENTILATED IN ACUTE CARE INPATIENT VENTILATOR UNIT. UPON APPLICATION OF THIS DEVICE, PATIENT WITH SIGNIFICANT INCREASED WORK OF BREATHING AND ACUTE CHANGE IN VITAL SIGNS. PATIENT NOT ABLE TO TOLERATE THERAPY DURATION AND THERAPY DISCONTINUED AFTER EACH ATTEMPT. THIS OCCURRED ON MULTIPLE OCCASIONS BEFORE DEVICE WAS PULLED FROM USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116612 VOLARA DEVICE, POSITIVE PRESSURE BREATHING, INTERMITTENT NHJ HILL-ROM MANUFACTURING, INC. PVL1

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Other