BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VELIA, FUKUDA - JAPAN

    MDR report key: 6054911 · Received October 25, 2016

    Report

    Report Number
    3004604967-2016-01152
    Event Type
    Injury
    Date Received
    October 25, 2016
    Report Date
    October 5, 2017
    Manufacturer
    RESMED GERMANY INC.
    Product Code
    MNT
    PMA / PMN Number
    K122715
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    RESMED HAS REQUESTED FOR THE DEVICE TO BE RETURNED SO THAT AN ENGINEERING INVESTIGATION COULD BE PERFORMED. THE DEVICE HAS NOT YET BEEN RETURNED, THEREFORE RESMED IS UNABLE TO CONFIRM THE ALLEGED MALFUNCTION AT THIS TIME. NOTE: PER THE STELLAR 100 USER GUIDE, (CONTRAINDICATION), THE STELLAR IS CONTRAINDICATED IN PATIENTS WHO ARE UNABLE TO ENDURE MORE THAN A BRIEF INTERRUPTION IN VENTILATION, THE STELLAR IS NOT A LIFE SUPPORT VENTILATOR. RESMED REFERENCE #: (B)(4).

    Additional Manufacturer Narrative · 1

    THE STELLAR DEVICE WAS NOT RETURNED TO RESMED FOR AN EXTENSIVE ENGINEERING INVESTIGATION. REVIEW OF THE DEVICE DATA LOGS CONFIRMED THAT NO CIRCUIT DISCONNECT ALARM WAS TRIGGERED IN THE DEVICE DURING PATIENT USE. THE INVESTIGATION DETERMINED THAT THE REPORTED CIRCUIT DISCONNECTED ALARM FAILURE WAS DUE TO A SOFTWARE ISSUE. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. NOTE: PER THE STELLAR 100 USER GUIDE, (CONTRAINDICATION), THE STELLAR IS CONTRAINDICATED IN PATIENTS WHO ARE UNABLE TO ENDURE MORE THAN A BRIEF INTERRUPTION IN VENTILATION, THE STELLAR IS NOT A LIFE SUPPORT VENTILATOR. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A STELLAR DEVICE'S DISCONNECTION ALARM FAILED TO TRIGGER WHEN A HOSPITAL PATIENT'S MASK FELL OFF. PER THE REPORTER, THE PATIENT WAS WITHOUT VENTILATION FOR ABOUT 2.5 HOURS. THE DELAY IN VENTILATION RESPONSE CAUSED THE PATIENT TO SUFFER AN ACUTE HEART FAILURE. THE PATIENT WAS STABILIZED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT A STELLAR DEVICE'S DISCONNECTION ALARM FAILED TO TRIGGER WHEN A HOSPITAL PATIENT'S MASK FELL OFF. PER THE REPORTER, THE PATIENT WAS WITHOUT VENTILATION FOR ABOUT 2.5 HOURS. THE DELAY IN VENTILATION RESPONSE CAUSED THE PATIENT TO SUFFER AN ACUTE HEART FAILURE. THE PATIENT WAS STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    704530 VELIA, FUKUDA - JAPAN MNT RESMED GERMANY INC. 24158

    Patients

    Seq Age Sex Outcome Treatment
    1