BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIRSENSE 10 CPAP USA CO

    MDR report key: 12662680 · Received October 19, 2021

    Report

    Report Number
    3007573469-2021-01086
    Event Type
    Malfunction
    Date Received
    October 19, 2021
    Date of Event
    August 12, 2021
    Report Date
    October 19, 2021
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    UDI-DI
    00619498372119
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION CAN BE PERFORMED. THE DEVICE HAS NOT BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. RESMED REFERENCE # (B)(4). MEDWATCH REPORT# 5103682.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT THE PRESSURE DELIVERED FROM AN AIRSENSE 10 CPAP WAS GREATER THAN 30 PSI. SERIOUS INJURY WITH REQUIRED INTERVENTION WAS REPORTED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1560663 AIRSENSE 10 CPAP USA CO BZD RESMED LTD 37203 00619498372119

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR