BEUDAMED
    FDA Adverse Event Injury Summary report: N

    1054260B

    MDR report key: 19371617 · Received May 22, 2024

    Report

    Report Number
    2518422-2024-30368
    Event Type
    Injury
    Date Received
    May 22, 2024
    Date of Event
    October 12, 2023
    Report Date
    April 24, 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
    NJ, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED 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 RESPIRATORY IRRITATION, KIDNEY DISEASE, TOXICITY, REDUCED CARDIO RESERVE, CANCER. MEDICAL INTERVENTIONS WERE NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. THE VENTILATOR WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND THE CUSTOMER'S COMPLAINT WAS NOT DUPLICATED. THE DEVICE OPERATED AND ALARMED AS DESIGNED. NO REPAIR PERFORMED DUE TO THE DEVICE NOT NEEDED FOR INVENTORY. THE UNIT WILL BE SCRAPPED. SECTION "ADVERSE EVENT/PRODUCT PROBLEM" IN BOX B HAS BEEN UPDATED/CORRECTED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE NOT RETURNED TO MANUFACTURER.

    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 RESPIRATORY IRRITATION, KIDNEY DISEASE, TOXICITY, REDUCED CARDIO RESERVE, CANCER. MEDICAL INTERVENTIONS WERE NOT SPECIFIED. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. 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
    1451787 1054260B VENTILATOR, CONTINUOUS, FACILITY USE CBK RESPIRONICS, INC. 1054260B 00606959026353

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other