BEUDAMED
    FDA Adverse Event Injury Summary report: N

    M-SERIES (DC) HEATED HUMIDIFIER CPAP SYSTEM

    MDR report key: 3202295 · Received June 26, 2013

    Report

    Report Number
    MW5030707
    Event Type
    Injury
    Date Received
    June 26, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 26, 2013
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE HUMIDIFIER STOPPED WORKING AND STARTED FLASHING CONTINUOUSLY. I FOLLOWED ALL STEPS DEFINED IN USER'S MANUAL WITHOUT LUCK. CONTACTED SUPPLIER AND MFR TO GET THE ISSUE ADDRESSED ALSO WITHOUT LUCK. I DID SOME RESEARCH AND FOUND THAT THIS EXACT SAME PRODUCT (M SERIES HUMIDIFIER MODEL# 1051158) HAS BEEN RECALLED IN THE (B)(4) FOR THE EXACT SAME PROBLEM I AM HAVING. THERE IS A US RECALL. (HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFRES/RES.CFM?ID=81028) ISSUED FOR THE SAME ISSUE BUT MY MODEL IS NOT LISTED IN THE US RECALL. THUS WHY THEY DON'T FEEL IT APPLIES. DOING SOME ADDITIONAL RESEARCHES I FOUND A BUNCH OF "ADVERSE EVENT REPORTS" ON THIS MODEL THAT CLEARLY REFER TO THE US FDA RECALL ABOVE EVEN THOUGH IT DOES NOT LIST THIS MODEL NUMBER. IF YOU READ HTTP://WWW.ACCESSDATA.FDA.GOV/SCRIPTS/CDRH/CFDOCS/CFMAUDE/DETAIL.CFM?MDRFOI_ID=1816044 WHICH IS CLEARLY IDENTIFIED AS MODEL# 1051158 AND SAYS RECALLED AS PART OF RECALL# Z-1260-2009 WHICH IS THE US FDA RECALL LISTED ABOVE. CLEARLY THIS UNIT DEFECTIVE AND SHOULD BE REPLACED BY THE SUPPLIER OR MFR AT NO COST TO ME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289654 M-SERIES (DC) HEATED HUMIDIFIER CPAP SYSTEM M-SERIES (DC) HEATED HUMIDIFIER CPAP SYSTEM BZD RESPIRONICS, INC. 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention