BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RESMED CPAP MASK RECALLED AIRFIT F20 & AIR SENSE 10 AUTO SET

    MDR report key: 19070359 · Received April 8, 2024

    Report

    Report Number
    MW5153645
    Event Type
    Injury
    Date Received
    April 8, 2024
    Date of Event
    September 27, 2020
    Report Date
    April 4, 2024
    Manufacturer
    RESMED CORP
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    UNCOMFORTABLE MASKS AND NOW RESMED MOST MASKS WERE AND ARE ON RECALLED. AIR BLOW OUT FROM RESMED CPAP (CONTINUOUS POSITIVE AIRWAY PRESSURE) AIR SENSE 10 AUTO SET WITH HEATED HUMIFIED MACHINES. CHOKING TO DEATH AND SUFFERING AND STILL SUFFERING SOFT TISSUE SWELLING ALL OVER THE BODY WITH INFLAMMATION ALL OVER THE JOINTS. RESMED INC. PUSH AWAY ALL THESE SERIOUS HARMS TO DEATH FOR YEARS. VERY IRRESPONSIBLE RESMED INC ORGANIZATIONS AND VERY ABUSIVE ORGANIZATION. DON'T CARE ONLY CARE ABOUT THEIR OWN PROFITS. WHOLE BACK IN PAIN WHEN GET UP IN THE MORNING. BURNING PAIN AND SWELLING FACE, CHINS, NECK, HANDS, FINGERS AND FEET.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION RECEIVED FROM REPORTER ON 4/18/2024 FOR REPORT MW5153645. BURNING PAINS ALL OVER THE BODY WITH SWELLING ALL OVER THE BODY AS WELL. DAMAGE ORGANS. RESMED INC ENGINEER CONFIRMED AS FOLLOWS THAT ANY CPAP MACHINE USER OF AIR SENSE 10 AUTO SET CAUSES SERIOUS HEALTH ISSUES: PER CLINICAL OPINION, SOFT TISSUE SWELLING OR INFLAMMATION IS DAMAGE OR INJURY TO THE MUSCLES, TENDONS AND LIGAMENTS. IT IS COMMONLY CAUSED BY EITHER ACUTE INJURY (DIRECT TRAUMA) OR OVERUSE/EXCESSIVE INJURIES OF THE INVOLVED TISSUE. SYMPTOMS INCLUDE PAIN, SWELLING AND BRUISING. TREATMENT PLANS CONSIST OF MEDICINE (ANTI-INFLAMMATORY, PAIN KILLERS, CORTICOSTEROIDS), PHYSICAL THERAPY AND ALSO REST. UNDER INTENDED OPERATING CONDITIONS OF THE DEVICE, IT IS NOT LIKELY THAT THE DEVICE AND/OR PAP THERAPY HAD CAUSED OR CONTRIBUTED TO THE PATIENT¿S SYMPTOMS AS THERE ARE NO DIRECT SKIN CONTACT BETWEEN THE DEVICE AND THE PATIENT¿S FACE, NECK OR BACK AREA. THE AIRSENSE 10 USER GUIDE PROVIDES THE FOLLOWING WARNING: - ¿PATIENTS SHOULD REPORT UNUSUAL CHEST PAIN, SEVERE HEADACHE, OR INCREASED BREATHLESSNESS TO THEIR PRESCRIBING PHYSICIAN. AN ACUTE UPPER RESPIRATORY TRACT INFECTION MAY REQUIRE TEMPORARY DISCONTINUATION OF TREATMENT¿. WHOLE BACK PAIN AND NOT ABLE TO GET UP AFTER 2 TIMES USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418280 RESMED CPAP MASK RECALLED AIRFIT F20 & AIR SENSE 10 AUTO SET VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED CORP 37035 1411908

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other| R| S| L