BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESMED AIRSENSE 10 - AUTOSET

    MDR report key: 18464142 · Received January 5, 2024

    Report

    Report Number
    MW5149904
    Event Type
    Malfunction
    Date Received
    January 5, 2024
    Date of Event
    June 1, 2022
    Report Date
    January 4, 2024
    Manufacturer
    RESMED CORPORATION
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY MOM WAS PRESCRIBED A CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) MACHINE FOR HER SLEEP APNEA (RESMED AIRSENSE 10- AUTOSET). SHE STARTED USING IT AROUND (B)(6) 2022. AFTER A FEW MONTHS (MAYBE 2-3 MONTHS) SHE HAD TO STOP USING IT BECAUSE THE MACHINE WILL SHUT OFF AUTOMATICALLY IN THE MIDDLE OF THE NIGHT AND MY MOM WILL WAKE UP BECAUSE SHE WAS FEELING THAT SHE WAS SUFFOCATING DUE TO THE LACK OF AIR. I TOOK THIS DEVICE TO THE DISTRIBUTOR, (B)(6) AND I TALKED WITH, WHOM I BELIEVE WAS THE ADMINISTRATOR OF THE OFFICE AND HE TOLD ME THAT HE COULD NOT DO ANYTHING ABOUT IT BECAUSE IT WAS A FLAW IN THE DESIGN OF THE DEVICE. THEY COULD NOT PROVIDE ME WITH ANOTHER PRODUCT. THE MONEY SPENT ON GETTING THIS DEVICE (FROM MEDICARE AND HER STATE BLUE CROSS BLUE SHEILD) WAS WASTED. I ALSO INFORMED THE HEALTHCARE PROVIDER WHO PRESCRIBED THIS DEVICE AND I WAS TOLD THAT THERE WAS NOTHING THAT THEY COULD DO ABOUT IT. I CANCELED HER UPCOMING FOLLOW-UP APPOINTMENT WITH THE PNEUMOLOGIST SINCE THERE WAS NO POINT TO DO A FOLLOW UP WHEN THE PRESCRIBED TREATMENT DOES NOT WORK; RATHER IT HARMS THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    688205 RESMED AIRSENSE 10 - AUTOSET VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED CORPORATION AIRSENSE 10 1624094

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Other BIOFREEZE| LEVOTHYROXINE | NITROGLYCERIN | PANTOPRAZOLE| TYLENOL | VOLTAREN CREAM