BEUDAMED
    FDA Adverse Event Death Summary report: N

    VPAP SV

    MDR report key: 2111671 · Received May 27, 2011

    Report

    Report Number
    3004604967-2011-00027
    Event Type
    Death
    Date Received
    May 27, 2011
    Date of Event
    April 1, 2011
    Report Date
    May 27, 2011
    Manufacturer
    RESMED LTD.
    Product Code
    MNS
    PMA / PMN Number
    K051364
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTER GAVE MINIMAL INFORMATION RELATING TO THE INCIDENT AND WOULD NOT PROVIDE ANY OTHER INFORMATION TO ALLOW RESMED TO INVESTIGATE. THE REPORTER STATED HE WAS NOT COMFORTABLE PROVIDING ANY FURTHER INFORMATION. THE REPORTER DID NOT ALLEGE A DEVICE MALFUNCTION. THE PRODUCT IS NOT BEING RETURNED, AND FROM THE LIMITED INFORMATION PROVIDED RESMED CANNOT CONFIRM A VPAP ADAPT WAS INVOLVED IN THIS INCIDENT. NOTE: THE VPAP ADAPT SV USER GUIDE STATES THE FOLLOWING: "THE VPAP ADAPT SV IS DESIGNED FOR USE WITH MASKS THAT ALLOW EXHALED GASES TO BE FLUSHED OUT THROUGH THE VENT HOLES. EXHALED GASES WILL BE REBREATHED IF THE MASK IS WORN WITH THE MACHINE OFF, OR IF THE VENT HOLES ARE OCCLUDED. IF THIS OCCURS OVER PROLONGED PERIODS, SUFFOCATION MAY OCCUR."

    Description of Event or Problem · 1

    ON (B)(6) 2011 RESMED WAS MADE AWARE OF A POSSIBLE PATIENT DEATH. THE REPORTER STATED A PATIENT WAS ILL AND WAS SENT TO THE LOCAL HOSPITAL. AT THE HOSPITAL, THE RESPIRATORY DEPARTMENT CHANGED THE PATIENT'S MASK FROM THE QUATTRO FX TO A NON VENTED MASK (THE PATIENT WAS REPORTEDLY ON THE RESMED VPAP ADAPT). PER THE REPORTER THE PATIENT PASSED AWAY SOME HOURS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VPAP SV MNS RESMED LTD. 26013

    Patients

    Seq Age Sex Outcome Treatment
    1 Death