BEUDAMED
    FDA Adverse Event Death Summary report: N

    AIRFIT F20 LGE - AMER

    MDR report key: 11898686 · Received May 27, 2021

    Report

    Report Number
    3004604967-2021-00640
    Event Type
    Death
    Date Received
    May 27, 2021
    Date of Event
    April 25, 2021
    Report Date
    August 19, 2021
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K161978
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESMED HAS REQUESTED RETURN OF THE DEVICE 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¿S RISK ASSOCIATED WITH USE OF THE DEVICE REMAINS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED TO RESMED THAT AN AIRFIT20 FULL FACE MASK WAS MAKING A STRANGE NOISE, THE MAGNET CLIP OF THE MASK HAD BROKE AND THE MASK SLIPPED OFF OF THE PATIENT'S FACE. SUBSEQUENTLY, THE PATIENT EXPIRED.

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED RETURN OF THE DEVICE 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#: PR (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AN AIRFIT20 FULL FACE MASK WAS MAKING A STRANGE NOISE, THE MAGNET CLIP OF THE MASK HAD BROKE AND THE MASK SLIPPED OFF OF THE PATIENT'S FACE. SUBSEQUENTLY, THE PATIENT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    791830 AIRFIT F20 LGE - AMER BZD RESMED LTD 63402

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death