BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY EVO, JAPAN

    MDR report key: 25340242 · Received May 29, 2026

    Report

    Report Number
    2518422-2026-017658
    Event Type
    Injury
    Date Received
    May 29, 2026
    Date of Event
    May 26, 2026
    Report Date
    May 29, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959051973
    PMA / PMN Number
    K181166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION FROM A FAMILY MEMBER ALLEGING THE PATIENT EXPERIENCED A TEMPORARILY DECREASED IN THEIR PERIPHERAL OXYGEN SATURATION (SPO2) AFTER THE DEVICE HAD ACCIDENTLY DROPPED ONTO THE FLOOR WHILE THE PATIENT WAS USING A TRILOGY EVO DEVICE. THE PATIENT'S SPO2 LEVEL HAD DROPPED FROM LOW 90'S TO THE LOW 70'S. THE VENTILATION WAS RESUMED AFTER THEY HAD REINFORCED THE DAMAGE AREA WITH VINYL TAPE, AND THE PATIENT'S CONDITION RECOVERED. A CIRCUIT DISCONNECTED ALARM OCCURRED ON THE DEVICE AT THE TIME OF THE EVENT. FURTHER INFORMATION THAT UPON REPORTING TO THE ATTENDING PHYSICIAN VIA ME, WE RECEIVED THEIR OPINION THAT THIS CASE RESULTED FROM PATIENT INATTENTION, AND NO PROBLEMS ARE OBSERVED ON THE DEVICE SIDE. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED BY THE PATIENT. PHILIPS IS CURRENTLY INVESTIGATING THIS COMPLAINT. THE DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS CURRENTLY AWAITING EVALUATION. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AS DUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212473 TRILOGY EVO, JAPAN VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. RJP2110X16B 00606959051973

    Patients

    Seq Age Sex Outcome Treatment
    1