BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RESMED AIRFIT N20 CPAP MASK

    MDR report key: 19152822 · Received April 19, 2024

    Report

    Report Number
    MW5154046
    Event Type
    Malfunction
    Date Received
    April 19, 2024
    Date of Event
    January 29, 2024
    Report Date
    April 17, 2024
    Manufacturer
    RESMED LTD./RESMED CORP
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NC, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    MY RESMED AIRFIT N20 CPAP HEADGEAR WAS THE SUBJECT OF A NATIONWIDE RECALL NUMBER Z-0539-2024, RECALL EVENT ID (B)(4). I HAVE REPEATEDLY CONTACTED RESMED AND MY DURABLE MEDICAL EQUIPMENT SUPPLIER, (B)(4), TO OBTAIN A REPLACEMENT OF THE UNSAFE HEADGEAR AND EACH ONE SAYS IT IS NOT HIS RESPONSIBILITY. RESMED SAYS "WE DON'T HAVE RECALLED PRODUCTS; WE ONLY UPDATED INSTRUCTIONS ONLINE. YOU MUST CALL YOUR HOME MEDICAL EQUIPMENT SUPPLIER." (B)(6) SAYS, "IT IS NOT OUR RECALL. IT IS RESMED'S RECALL." IT IS CONTRARY TO THE EXPECTATIONS OF A PRODUCT RECALL FOR THE MANUFACTURER AND THE DISTRIBUTOR TO ABDICATE RESPONSIBILITY AND TO DO NOTHING TO REPLACE DEFECTIVE AND UNSAFE PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1190184 RESMED AIRFIT N20 CPAP MASK VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED LTD./RESMED CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female CPAP MACHINE.