BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRILOGY 100 VENTILATOR

    MDR report key: 19198979 · Received April 27, 2024

    Report

    Report Number
    2518422-2024-23150
    Event Type
    Injury
    Date Received
    April 27, 2024
    Date of Event
    March 28, 2024
    Report Date
    July 16, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    CBK
    UDI-DI
    00606959026353
    PMA / PMN Number
    K083526
    Removal / Correction Number
    Z-1956-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURE.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THAT A MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING EYE IRRITATION, DIZZINESS, HEADACHE, RESPIRATORY TRACT IRRITATION, HYPERSENSITIVITY, ASTHMA, NOSE IRRITATION, SKIN IRRITATION, NAUSEA AND VOMITING. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMERS COMPLAINT WAS NOT DUPLICATED. THE DEVICE OPERATED AND ALARMED AS DESIGNED. NO REPAIRS WERE PERFORMED. IT WAS NOTED THAT THE DEVICE WAS NOT NEEDED FOR INVENTORY AND THE UNIT WAS SCRAPPED THE MANUFACTURER PREVIOUSLY REPORTED THE FDA PRODUCT CODE: BZD. THE FDA PRODUCT CODE IS: CBK THE MANUFACTURER PREVIOUSLY NOT REPORTED THE RECALL NUMBER. THE CORRECT RECALL NUMBER IS: Z 1956-2021 UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING EYE IRRITATION, DIZZINESS, HEADACHE, RESPIRATORY TRACT IRRITATION, HYPERSENSITIVITY, ASTHMA, NOSE IRRITATION, SKIN IRRITATION, NAUSEA AND VOMITING. MEDICAL INTERVENTION WAS NOT SPECIFIED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2307701 TRILOGY 100 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE. CBK RESPIRONICS, INC. 1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other