BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY EVO

    MDR report key: 19184382 · Received April 24, 2024

    Report

    Report Number
    MW5154304
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Date of Event
    March 29, 2024
    Report Date
    April 22, 2024
    Manufacturer
    PHILLIPS/RESPIRONICS INC.
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON (B)(6) 2024 A LOCAL DME, PERFORMANCE HOME MEDICAL, PROVIDED US WITH A PHILLIPS TRILOGY EVO AND DID NOT DISCLOSE THAT IT IS CURRENTLY PART OF AN ACTIVE CLASS 1 RECALL. WE FOUND THIS OUT OURSELVES WHEN TROUBLESHOOTING THE MACHINE (THE MASK FIT OR PRESSURE WASN'T WORKING OUT FOR MY HUSBAND). I MATCHED THE SERIAL NUMBER TO THE RECALL AND REACHED OUT TO THE COMPANY WHO TOLD ME THAT IT WASN'T RECALLED - EVEN THOUGH THE SERIAL NUMBER SAYS IT IS. I'M NOT SURE WHY THEY'RE DISTRIBUTING RECALLED VENTILATORS, WITH NO WARNING, TO TERMINALLY ILL ALS PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879241 TRILOGY EVO VENTILATOR, CONTINUOUS, FACILITY USE CBK PHILLIPS/RESPIRONICS INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male