BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRILOGY 100

    MDR report key: 3913107 · Received May 14, 2014

    Report

    Report Number
    2518422-2014-00783
    Event Type
    Malfunction
    Date Received
    May 14, 2014
    Date of Event
    April 18, 2014
    Report Date
    March 31, 2022
    Manufacturer
    RESPIRONICS INC.
    Product Code
    CBK
    PMA / PMN Number
    K083526
    Removal / Correction Number
    FDA RES 88071
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

    DURING THE EVALUATION OF THE DEVICE AT THE MANUFACTURER¿S SERVICE CENTER, "VENTILATOR INOPERATIVE" AND "SERVICE REQUIRED" CODES WERE FOUND IN THE VENTILATOR'S DOWNLOADED ERROR LOG. THE DEVICE'S BLOWER MOTOR AND SYSTEM BOARD WERE REPLACED TO ADDRESS THE ISSUES. THE DEVICE HAD EVIDENCE OF TAMPERING.

    Description of Event or Problem · 1

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING A VENTILATOR ALARMED AND POWERED OFF. THERE WAS NO HARM OR INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287894 TRILOGY 100 VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS INC. 1054260

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown