BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED AIRSENSE 10

    MDR report key: 23435995 · Received October 31, 2025

    Report

    Report Number
    MW5178321
    Event Type
    Injury
    Date Received
    October 31, 2025
    Date of Event
    April 1, 2025
    Report Date
    October 9, 2025
    Manufacturer
    PPC MOULDING SERVICES PTY LTD
    Product Code
    BZD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NY, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE PRODUCT IS RESMED AIRSENSE 10. THE CPAP HAS AN AIR LEAK. THE SUPPLIER REFUSES, POINT BLANK, TO SEND A SLEEP THERAPIST. OVERALL, THE MACHINE IS DEFECTIVE AND APRIA REFUSES TO SERVICE ETC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1701930 RESMED AIRSENSE 10 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD PPC MOULDING SERVICES PTY LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Disability AZELASTINE.| BREO ELLIPTA.| CETIRIZINE.| FLUCYTOSINE.| INCRUSE ELLIPTA.| IPRATROPIUM.