BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CPAP MODEL M-SERIES HEATED HUMIDIFIER-DOM

    MDR report key: 5503830 · Received March 13, 2016

    Report

    Report Number
    MW5060917
    Event Type
    Injury
    Date Received
    March 13, 2016
    Date of Event
    March 1, 2016
    Report Date
    March 13, 2016
    Manufacturer
    RESPIRONICS
    Product Code
    BTT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    MY RESMED CPAP MACHINE MODEL NO. M-SERIES HEATED HUMIDIFIER - DOM; MODEL #: 1051158; SERIAL NUMBER (B)(4) IS SMELLING LIKE SOMETHING IS BURNING. NO SMOKE VISIBLE BUT THE SMELL LINGERS WHEN THE MACHINE IS USED THEN TURNED OFF. HEATED HUMIDIFIER DOES NOT WORK. I FOLLOWED ALL INSTRUCTIONS AND MAINTENANCE, BUT IT NOT RIGHT. HOW CAN I GET A FREE REPLACEMENT OF THIS MACHINE THAT WILL NOT HAVE THIS EFFECT?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152639 CPAP MODEL M-SERIES HEATED HUMIDIFIER-DOM CPAP BTT RESPIRONICS 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention