BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100 VENTILATOR

    MDR report key: 13059554 · Received December 20, 2021

    Report

    Report Number
    MW5106177
    Event Type
    Malfunction
    Date Received
    December 20, 2021
    Report Date
    December 16, 2021
    Manufacturer
    PHILIPS / RESPIRONICS, INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    TRILOGY 100 VENTILATOR WAS RECALLED. THEY ARE NOT REPLACING AN APPROPRIATE ITEM WITH THE DME SUPPLIER. PHILIPS WANTS THE DME COMPANY TO FIX IT THEMSELVES WHICH WOULD VOID THE WARRANTY AS ALL OTHER PM MAINTENANCE IS COMPLETED BY PHILIPS ALWAYS. SO THERE IS NO POSSIBILITY OF TAKING THE PERSON OFF OF THE VENTILATOR. THERE ARE NO OTHER VENTILATORS UNLESS THE DME COMPANY BUYS ALL NEW VENTILATORS. THE WHOLE COUNTRY AS YOU KNOW IS LIMITED VENTILATOR SUPPLY. THE DME COMPANY WAS NOT ASKED TO REPORT THIS TO FDA BUT ONLY ASKED FOR A NAME OF CLIENT'S ON THEIR PRODUCT. PHILIPS CANNOT BE CONTACTED. THIS TRILOGY IN OUR HOME IS SHOWING THE BLACK SPOTS ON THE FILTER. PATIENT CANNOT SPEAK SO UNSURE HOW THIS IS AFFECTING. I AM HEREBY REQUESTING SOME HELP TO SOLVE THIS POTENTIALLY DANGEROUS PROBLEM. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1939666 TRILOGY 100 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILIPS / RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Male