BEUDAMED
    FDA Adverse Event Injury Summary report: N

    S8 VANTAGE AUTO CORE

    MDR report key: 2495937 · Received March 14, 2012

    Report

    Report Number
    MW5024668
    Event Type
    Injury
    Date Received
    March 14, 2012
    Date of Event
    March 13, 2012
    Report Date
    March 14, 2012
    Manufacturer
    RESMED
    Product Code
    BYE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    UT, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    THE CPAP I USE FOR MY SLEEP APNEA JUST SHUTS OFF WHILE IN USE. THE SUDDEN LACK OF AIR FLOW AND SUBSEQUENT DIFFICULTY WAKE ME UP. THIS HAPPENED TWO TIMES ON THE EVENING OF (B)(6) 2012. THIS HAS HAPPENED BEFORE MULTIPLE TIMES AND WHEN I CONTACT THE DME COMPANY THEY CANNOT OR WILL NOT HELP. THE LAST INCIDENT WAS (B)(6) 2012. I HAVE HAD AT LEAST TWO DIFFERENT NIGHTS WHEN THE MACHINE SHUT OFF MORE THAN 4 TIMES DURING THE NIGHT. AT FIRST I THOUGHT IT WAS A POWER PROBLEM (IE DIRTY POWER) BECAUSE IT SEEMED TO HAPPEN MOSTLY WHEN I WAS AWAY FROM HOME. IT IS ALWAYS PLUGGED INTO A SURGE PROTECTOR- BUT I BEGAN USING A SURGE PROTECTOR AWAY FROM HOME AND THE PROBLEM PERSISTED AND BEGAN HAPPENING AT HOME ALSO. THIS PROBLEM NOT ONLY DISRUPTS MY SLEEP BUT I WORRY THAT ONE DAY THE SUDDEN LACK OF AIR WILL NOT WAKE ME UP AND THIS DEVICE MALFUNCTION MAY CONTRIBUTE TO OR CAUSE SUFFOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 S8 VANTAGE AUTO CORE CPAP BYE RESMED S8 VANTAGE AUTO CORE

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Life Threatening| O