BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRFIT N30I CUSHION

    MDR report key: 14602218 · Received June 3, 2022

    Report

    Report Number
    MW5110115
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 27, 2022
    Report Date
    June 2, 2022
    Manufacturer
    RESMED CORP
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    I SUFFER FROM OBSTRUCTIVE SLEEP APNEA AND USE A CPAP MACHINE AS PRESCRIBED BY MY SLEEP DOCTOR. I RECENTLY ORDERED NEW SUPPLIES FOR MY CPAP MACHINE FROM MY DME PROVIDER, HME FULFILLMENT LLC BASED IN (B)(6). THE ORDER CONSISTED OF A TUBE, FILTERS, RESMED NASAL MASK STARTER KIT, AND RESMED N30I NASAL CUSHIONS. THE NASAL CUSHIONS ALL ARRIVED INDIVIDUALLY PACKAGED IN A ZIP LOCK BAG WITH NO MANUFACTURER LABELING. THE RESMED NASAL MASK STARTER KIT WAS OPENED AND THE NASAL CUSHIONS THAT WERE MEANT TO BE THERE AS PART OF A STANDARD STARTER KIT WERE MISSING. I CALLED UP RESMED AND THEY CONFIRMED THAT THE NASAL CUSHIONS SHOULD ALWAYS BE PACKAGED AND SEALED INDIVIDUALLY, AND INCLUDE A MEDICAL LABEL. MY GUESS IS THAT THE DME IS OPENING UP THE STARTER KITS AND KEEPING ALL THE EXTRA NASAL CUSHIONS THAT ARE NOT OF THE SIZE THAT THEY BELIEVE THEIR CUSTOMER USES AND ARE REPACKAGING THESE UP FOR SALE. THIS IS CLEARLY ILLEGAL AND IN ESSENCE CONSTITUTES INSURANCE FRAUD AS WELL AS MY INSURANCE COMPANY IS BILLED FOR INDIVIDUAL BRAND NEW NASAL CUSHIONS AND NOT REPACKAGED ONES FROM STARTER KITS. FDA SAFETY REPORT ID # (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305310 AIRFIT N30I CUSHION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESMED CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male