BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY 100

    MDR report key: 14976507 · Received July 8, 2022

    Report

    Report Number
    MW5110774
    Event Type
    Injury
    Date Received
    July 8, 2022
    Date of Event
    August 14, 2021
    Report Date
    July 6, 2022
    Manufacturer
    RESPIRONICS INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    SINCE STILL USING RECALLED VENTILATOR, I AM EXPERIENCING RUNNY NOSE, HEADACHES, EYE AND SKIN IRRITATIONS YET PHILIPS CANNOT GIVE ME A DATE WHEN I WILL GET REPLACEMENT AND I'M STILL HAVING TO PAY MONTHLY TO APRIA FOR A RECALLED VENTILATOR WHICH IS MY LIFELINE. IT IS LONG OVERDUE, AND MY HEALTH ALREADY KEEPS ME BEDRIDDEN. I SUFFER FROM ALS THIS MACHINE IS VITAL FOR ME. I'M TIRED OF BEING PUT ON HOLD TO GET THIS REPLACED. EVERY TIME MY CAREGIVER CALLS TO GET UPDATE ALL THEY SAY EVERY TIME OH WE WILL PUT HER ON THE PRIORITY LIST WELL EACH TIME CAREGIVER GETS TOLD THEM DO, THEY REALLY HAVE PRIORITY LIST AND AM I REALLY ON IT.? THIS IS UNPROFESSIONAL AND MY HEALTH SHOULD NOT SUFFER DUE TO THEIR LACK OF FIXING THE PROBLEM. I TRULY FEEL THEY ARE JUST WAITING FOR ME TO DIE SO THEY DON'T HAVE TO REPLACE THIS. WHEN WILL THIS GET REPLACED? FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2396151 TRILOGY 100 VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS INC. MO40818

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Disability OXYCODONE 5 MG ATIVAN VENTILATOR, TRACHEA, RESPIRATOR, NEBULIZER MACHINE.