BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP AIRSENSE 10

    MDR report key: 10282893 · Received July 15, 2020

    Report

    Report Number
    MW5095551
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    July 1, 2020
    Report Date
    July 14, 2020
    Manufacturer
    RESMED CORPORATION
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    TOOK MY CPAP TO A LOCAL BUSINESS AND THEY MADE CHANGES ON THE SETTINGS WITHOUT AN RX. HAD TO CONSULT MY (B)(4) COMPANY FOR HELP REVERSE ADJUSTMENTS. (B)(6). FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738704 CPAP AIRSENSE 10 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention