BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED AIRSENSE 11

    MDR report key: 17720106 · Received September 8, 2023

    Report

    Report Number
    MW5145460
    Event Type
    Injury
    Date Received
    September 8, 2023
    Date of Event
    August 21, 2023
    Report Date
    September 5, 2023
    Manufacturer
    RESMED CORP.
    Product Code
    BZD
    UDI-DI
    00619498394852
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    THE SETTINGS ON MY CPAP DEVICE CHANGED UNEXPECTEDLY (RESMED AIRSENSE 11, S/N (B)(6)). SPECIFICALLY, IN EARLY (B)(6) 2023, I NOTICED THAT THE DEVICE WAS STARTING AT A DIFFERENT PRESSURE. I THEN CONTACTED LINCARE (PHONE NUMBER (B)(6)) AND SPOKE WITH A TECHNICIAN ("(B)(6)") INQUIRING WHY IT CHANGED. HE SAID ON THAT DATE, THAT HE HAD "NEVER SEEN ANYTHING LIKE THIS BEFORE" AS THE SYSTEM SHOWED A CHANGE THAT WAS COMMANDED, BUT NO LOG OF WHO MADE THE CHANGE. HE THUS INVESTIGATED AND WAS GOING TO GET BACK WITH ME ON WHY THEY CHANGED. I CALLED ON (B)(6), TO FOLLOW UP AND I TALKED TO "(B)(6)" SINCE (B)(6) WAS UNAVAILABLE. (B)(6) TOLD ME THAT THE SETTINGS GOT CHANGED IN "CLINICIAN" MODE VIA THE DEVICE'S USER INTERFACE. HOWEVER NO CLINICIAN VISITED MY HOME. HE THEN CLAIMED I MUST HAVE ACCIDENTALLY CHANGED IT. I ASKED IS AUTHENTICATION IS REQUIRED - HE SAID "NO". I THEN ASKED IF IT IS POSSIBLE TO ACCIDENTALLY GET TO THAT SCREEN. HE SAID "NO". I KNOW I DID NOT CHANGE ANYTHING AND TOLD HIM SO. NOT ONLY DID THE STARTING PRESSURE CHANGE, BUT THE PRESCRIPTION COMPLETELY CHANGED. E.G. INSTEAD OF OPERATING AS AN A-PAP MACHINE, IT NOW CHANGED TO A STANDARD CPAP MACHINE AND AT DIFFERENT PRESSURE LEVELS. HE THEN SENT COMMANDS TO CHANGE THE DEVICE SETTINGS BACK TO MY PRESCRIPTION. THE DEVICE THEN RECEIVED THE ORIGINAL SETTINGS AND IS NOW OPERATING CORRECTLY. WHILE THIS IS NOT A MAJOR CONCERN FOR ME, I AM VERY CONCERNED ABOUT THE POTENTIAL IMPACT ON OTHER PATIENTS. I USED TO WORK FOR DELPHI MEDICAL SYSTEMS AS THE LEAD MEDICAL DEVICE ENGINEER ON A VITAL SIGNS MONITOR, SO I KNOW HOW CRITICAL IT IS FOR DEVICE TO OPERATE CORRECTLY. I ALSO WORK ON PRODUCT CYBERSECURITY, ENSURING DEVICES DON'T GET "HACKED" AS THAT IS MY PROFESSIONAL JOB. I AM WONDERING IF EITHER IT GOT CHANGED BY AN ATTACKER OR SOMETHING ELSE HAPPENED. I THINK THIS WARRANTS AN INVESTIGATION SINCE IT COULD IMPACT OTHER PATIENTS. PLEASE NOTE THE PICTURE I ATTACHED IS ONLY OF THE DEVICE'S SERIAL NUMBER AND RELEVANT DEVICE IDENTIFICATION NUMBERS. PLEASE CONTACT ME IF YOU HAVE ANY QUESTIONS. THANK YOU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2061945 RESMED AIRSENSE 11 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED CORP. AIRSENSE 11 1667849 00619498394852

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male Required Intervention