BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEATED HUMIDIFIER DC ASSY. - DOM

    MDR report key: 19495862 · Received June 10, 2024

    Report

    Report Number
    2518422-2024-35367
    Event Type
    Injury
    Date Received
    June 10, 2024
    Date of Event
    October 12, 2023
    Report Date
    June 10, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL NUMBER (1051158) AND SERIAL NUMBER ((B)(6)) REPORTED CORRESPOND TO A HUMIDIFIER. THE BASE DEVICE IS UNKNOWN BUT HAS BEEN REPORTED AS A BIPAP AUTO BIFLEX W/HUM SYS ONE, AS THIS IS THE MOST LIKELY CORRESPONDING PRODUCT.

    Description of Event or Problem · 0

    THE MANUFACTURER WAS NOTIFIED ABOUT A VOLUNTARY FIELD SAFETY NOTICE/RECALL RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED REPORTS ALLEGING THAT PATIENTS EXPERIENCED RESPIRATORY TRACT IRRITATION AND ASTHMA - NEW OR WORSENING. NO SPECIFIC MEDICAL INTERVENTION WAS MENTIONED. THE MANUFACTURER WAS MADE AWARE OF THIS INFORMATION THROUGH THE CUSTOMER¿S LEGAL REPRESENTATIVE. DUE TO POTENTIAL LEGAL ISSUES SURROUNDING THIS CASE, NO FURTHER INVESTIGATION OR FOLLOW-UP CAN BE CONDUCTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2125864 HEATED HUMIDIFIER DC ASSY. - DOM VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 1051158

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other