BEUDAMED
    FDA Adverse Event Death Summary report: N

    S9 VPAP ST - AM

    MDR report key: 11904693 · Received May 28, 2021

    Report

    Report Number
    3004604967-2021-00644
    Event Type
    Death
    Date Received
    May 28, 2021
    Date of Event
    September 16, 2020
    Report Date
    May 28, 2021
    Manufacturer
    RESMED LTD
    Product Code
    BZD
    PMA / PMN Number
    K102513
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. THE S9 VPAP ST IS NOT INTENDED TO BE USED AS A LIFE SUPPORT VENTILATOR AND AN INDICATED PATIENT WOULD STILL BE ABLE TO CONTINUE TO BREATHE SPONTANEOUSLY. RESMED'S RISK ANALYSIS FOR THIS FAILURE MODE CONCLUDES THAT THE RISK IS ACCEPTABLE. RESMED REFERENCE#: (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO RESMED THAT AT THE TIME A PATIENT WAS FOUND DECEASED WHILE USING AN S9 VPAP ST, THE S9 VPQP ST WAS FOUND NOT WORKING, DISPLAYING PLEASE CLOSE H5I, FLIP LID ATTACH TUBE AND PRESS ANY KEY ON THE SCREEN, THE LID OF THE H5I HUMIDIFIER WAS NOT CLOSED AND THERE WAS NO AUDIBLE ALARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    801401 S9 VPAP ST - AM BZD RESMED LTD 36008A

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death