BEUDAMED
    FDA Adverse Event Death Summary report: N

    H4I - EUR GP2, UK, AP

    MDR report key: 12748144 · Received November 3, 2021

    Report

    Report Number
    3004604967-2021-01120
    Event Type
    Death
    Date Received
    November 3, 2021
    Date of Event
    June 1, 2021
    Report Date
    July 25, 2022
    Manufacturer
    RESMED LTD
    Product Code
    MNT
    PMA / PMN Number
    K122715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE STELLAR DEVICE AND H4I HUMIDIFIER WERE RETURNED TO RESMED FOR AN INVESTIGATION. THE INVESTIGATION DETERMINED THAT THERE WAS NO FAULT FOUND WITH THE RETURNED DEVICE. THE DEVICE WAS PERFORMING TO SPECIFICATIONS. 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 THE H4I HUMIDIFIER OF A STELLAR WAS USED WITHOUT WATER FILLED BY THE CAREGIVER, THEREFORE ALLEGEDLY DELIVERING DRY AIR TO THE PATIENT WHICH CONTRIBUTED TO RESPIRATORY DETERIORATION AND SUBSEQUENT DEATH OF THE PATIENT. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION.

    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).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT THE H4I HUMIDIFIER OF A STELLAR WAS USED WITHOUT WATER FILLED BY THE CAREGIVER, THEREFORE ALLEGEDLY DELIVERING DRY AIR TO THE PATIENT WHICH CONTRIBUTED TO RESPIRATORY DETERIORATION AND SUBSEQUENT DEATH OF THE PATIENT. THERE IS NO ALLEGATION OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1644553 H4I - EUR GP2, UK, AP MNT RESMED LTD 26942

    Patients

    Seq Age Sex Outcome Treatment
    1 15 YR Unknown Death