BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOODKNIGHT 420G CPAP

    MDR report key: 859367 · Received June 4, 2007

    Report

    Report Number
    MW5002154
    Event Type
    Injury
    Date Received
    June 4, 2007
    Date of Event
    May 14, 2007
    Manufacturer
    TALK ABOUT SLEEP, INC.
    Product Code
    NHJ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IN 2007, WITH DOCTOR'S PRESCRIPTION, I ORDERED "GOOD NIGHT 420G CPAP" BREATHING SUPPORT MEDICAL MACHINE FOR SLEEP APNEA. SIX DAYS LATER, A COMPANY DELIVERED THE MACHINE; I PLUGGED IT IN AND NOTICED THE "420G CPAP" MACHINE CONSTANTLY TURNS ON/OFF. IT WON'T KEEP PRESSURE EVEN IF I REDUCE THE AIR FLOW BY 90%. THE MACHINE ALSO SMELLS OF BURNING PLASTIC, AND I DO NOT WANT TO BE BREATHING IN THE SMELL OF BURNT PLASTIC. I THEN CALLED A REP FROM "TALK ABOUT SLEEP" AND ASKED TO RETURN THE MACHINE BACK BECAUSE IT DOES NOT WORK PROPERLY AND IT SMELLS OF BURNED PLASTIC. THEY HUNG UP THE PHONE ON ME TWO TIMES, YELLED AT ME, AND TOLD ME, "NO RETURNS; YOU BUY IT, IT'S YOURS." THIS IS A MEDICAL DEVICE; I DON'T WANT A DEVICE THAT MAY BE POISONOUS AND GET ME SICK. THEY SOLD ME A MALFUNCTIONED MACHINE WHICH CAN HARM MY BODY; THEREFORE, I WANT MY FULL REFUND BACK.

    Description of Event or Problem · 1

    .

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GOODKNIGHT 420G CPAP NONE NHJ TALK ABOUT SLEEP, INC. CPAP G420

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Life Threatening| O