BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRANSCEND 365 MINICPAP SYSTEM

    MDR report key: 12590176 · Received October 6, 2021

    Report

    Report Number
    MW5104459
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 4, 2021
    Report Date
    October 6, 2021
    Manufacturer
    SOMNETICS INTERNATIONAL, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CONGESTION; I HAVE HAD MULTIPLE ISSUES WITH THIS DEVICE. SEVERAL RETURNS/REWORKS WITH NO IMPROVEMENTS. UNIT WILL STOP WORKING, HUMIDIFIER ISSUES, ETC. REPEATED RETURNS (3) AND THEY EITHER REWORKED THE UNIT (2X) AND CLAIMED TO PROVIDE NEW (BUT IT WAS REFURBISHED). I HAVE USED THE RECOMMENDED WATER, CHANGED FILTERS AND FOLLOWED THE GUIDELINES OF THE INSTRUCTIONS AS RECOMMENDED. UNIT STILL WILL NOT WORK RELIABLY AND HAS CAUSED REACTIONS; INCLUDING COUGHING, NASAL BLOCKAGE, TIREDNESS AS A RESULT OF THE UNIT NOT WORKING AS PRESCRIBED. THE MANUFACTURER CLAIMS THE ISSUES ARE RELATED TO DUST. THE FILTER IS CLEANED AS INSTRUCTED; A HEPA FILTER SYSTEM IS IN THE ROOM THE DEVICE IS USED, THE UNIT IS CLEANED DAILY. A FRIEND WHO WORKS IN THE MEDICAL DEVICE INDUSTRY AND INDICATED THAT I SHOULD REPORT THIS ISSUE IMMEDIATELY. THIS IS A MANUFACTURER ISSUE WHICH IS RESULTING IN PATIENT HARM. THE MANUFACTURER HAS NOT REPORTED ANY OF THE COMPLAINTS TO DATE ON PER THE REQUIREMENTS OF 21 CFR PART 803. I AM CURRENTLY LOOKING AT OTHER MANUFACTURERS OF THIS DEVICE AND WHO WOULD SEEM TO FOLLOW FDA REQUIREMENTS FOR MARKETING A DEVICE. THE PROCODE IS BZD FOR THE 510K (K180388). FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1485126 TRANSCEND 365 MINICPAP SYSTEM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD SOMNETICS INTERNATIONAL, INC. TRANSCEND 365 16D20200122W

    Patients

    Seq Age Sex Outcome Treatment
    1 Other