BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRILOGY EVO, USA-RECERT

    MDR report key: 20521721 · Received October 24, 2024

    Report

    Report Number
    2518422-2024-102570
    Event Type
    Death
    Date Received
    October 24, 2024
    Date of Event
    September 14, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959060500
    PMA / PMN Number
    K181166
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER REVIEW AND INVESTIGATION OF THIS REPORT ON (B)(6) 2025 INDICATES THAT THIS COMPLAINT RECORD WITH MDR # 2518422-2024-102570 SUBMITTED ON (B)(6) 2024 IS A DUPLICATE OF THE COMPLAINT RECORD ASSIGNED MDR # 2518422-2024-103309 WHICH WAS SUBMITTED ON (B)(6) 2024 (PHILIPS SRC TW (B)(4)). PLEASE CONSIDER THIS AS NOTIFICATION OF FINAL REPORTING ON MDR # 2518422-2024-102570 AND REFER INSTEAD TO MDR # 2518422-2024-103309.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION THAT A PATIENT ON VENTILATOR THERAPY WITH A TRILOGY EVO VENTILATOR BECAME UNRESPONSIVE ON (B)(6) 2024. SUBSEQUENTLY, 911 WAS CALLED AND THE PATIENT WAS TAKEN TO THE HOSPITAL IN AN AMBULANCE. CARDIOPULMONARY RESUSCITATION WAS ATTEMPTED ENROUTE TO THE HOSPITAL. THE PATIENT ULTIMATELY PASSED AWAY. A CAUSE OF DEATH IS NOT KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425502 TRILOGY EVO, USA-RECERT PORTABLE ELECTRIC VENTILATOR CBK RESPIRONICS, INC. UDS2110X11B 00606959060500

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Male Death