BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCUSOM MODEL NS 2010

    MDR report key: 9665130 · Received February 3, 2020

    Report

    Report Number
    MW5092709
    Event Type
    Malfunction
    Date Received
    February 3, 2020
    Date of Event
    January 30, 2020
    Report Date
    January 30, 2020
    Manufacturer
    NOVASOM, INC.
    Product Code
    MNR
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TN, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    PREVENTS SLEEPING; I WAS SENT A ACCUSOM MODEL NS 2010 FOR A SLEEP STUDY ORDERED BY DR (B)(6), MY PRIMARY CARE PHYSICIAN. EVERY TIME I STARTED TO FALL ASLEEP AND MY BREATHING GOT SHALLOW, THE DEVICE SAID "CHECK BREATH SENSOR" AND WOKE ME UP. HEAVY BREATHING ON THE DEVICE OR BLOWING ON IT WOULD RESET IT. AFTER FIVE WARNINGS, I CALLED THE PRODUCT SUPPORT NUMBER. THAT WAS 7 AM. THEY HAD ME UNPLUG THE SENSOR AND PLUG IT BACK IN, UNTAPE IT FROM MY FACE AND REPOSITION IT, AND TOLD ME IF IT KEPT UP TO STOP TESTING, AND THEY WOULD SEND ME A NEW SENSOR. I DON'T BELIEVE THE SENSOR IS MALFUNCTIONING. I FEEL LIKE IT WAKES ME WHEN MY BLOOD OXYGEN DROPS BELOW 90%. WHICH IT COMMONLY DOES WHEN I SLEEP, AND IS WHY I WANTED THE SLEEP STUDY. THE STAFF DIDN'T THINK IT WORKED THAT WAY; BUT DIDN'T REALLY SEEM TO KNOW HOW THEIR DEVICE ACTUALLY WORKS. I KEPT TRYING TO REPOSITION AND GO TO SLEEP FOR AN ADD'L HOUR, AND THREE MORE REITERATIONS OF "CHECK BREATH SENSOR" AND QUIT AT 3 AM. IT'S A GOOD THING I DIDN'T HAVE TO GO TO WORK THE NEXT DAY, OR DRIVE ON FOUR HOURS OF SLEEP. A SLEEP STUDY DEVICE THAT HAS A DEFECTIVE SENSOR AND WON'T LET YOU SLEEP, ISN'T SAFE. ALL THEIR CLINICAL SPECIALISTS WERE UNAVAILABLE WHEN I CALLED THE NEXT DAY. I ASKED MY DR TO TRY AND REACH THE COMPANY, BUT SHE HASN'T GOTTEN BACK TO ME EITHER. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123685 ACCUSOM MODEL NS 2010 VENTILATORY EFFORT RECORDER MNR NOVASOM, INC. NS 2010

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other