BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AIRSENSE 11

    MDR report key: 21950471 · Received May 2, 2025

    Report

    Report Number
    MW5169803
    Event Type
    Injury
    Date Received
    May 2, 2025
    Date of Event
    October 22, 2022
    Report Date
    April 24, 2025
    Manufacturer
    RESMED LTD/RESMED CORP.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    PATIENT
    Health Professional
    N

    Narratives

    Description of Event or Problem · 0

    SN: (B)(6), REF: 39485, LOT: 1655462, FCC ID: 2ACHL-AIR11M1, IC ID: 9103A-AIR11M1. THE DATA ON THE MACHINE ITSELF DOES NOT MATCH THE TIME I AM USING THE MACHINE FOR, AND THEREFORE, PERIODS OF TIME WHERE THE MACHINE IS BLOWING AIR ARE COMPLETELY UNACCOUNTED FOR RESMED AIRSENSE 11 PROBLEM. SERIOUS ADVERSE EVENTS WHICH MAY BE ATTRIBUTED TO THE MACHINE MALFUNCTION HAVE OCCURRED. OR EXAMPLE: COGNITIVE PROBLEMS. FEELING LIKE I AM DYING. EMERGENCY ROOM. DOCTOR APPOINTMENTS. DRIVING ISSUES. PAST EVENTS RELATED TO MEDICAL DEVICES WORTH NOTING: I THINK MY LAST CPAP DEVICE MALFUNCTIONED AS WELL. I DO NOT HAVE THE DEVICE. I AM UNABLE TO LOCATE IT. I HAVE SEEN AN IV PUMP (MY DAD'S). FLOOD INSTEAD OF DRIP. I THINK THIS WAS IN (B)(6) OF 2014. I REPORTED IT TO THE FBI CYBERCRIME. I RECEIVED NO RESPONSE DESPITE RECORDS ON MULTIPLE OCCASIONS. OTHER CYBERCRIME AND FRAUD. PATTERNS OF IT. THE PREVIOUS CPAP I WAS USING WAS A RESPIRONICS DEVICE, BUT I AM UNABLE TO LOCATE IT. THIS DEVICE LOOKS AS IF IT IS BEING HACKED, ESPECIALLY SINCE I HAD ISSUES WITH THE LAST CPAP AS WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1895307 AIRSENSE 11 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED LTD/RESMED CORP. 39485 1655462

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female Disability| R| L| H CPAP