BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NO EQUIPMENT NUMBER

    MDR report key: 20561829 · Received October 29, 2024

    Report

    Report Number
    2518422-2024-102879
    Event Type
    Injury
    Date Received
    October 29, 2024
    Date of Event
    September 5, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE PREVIOUS FOLLOW-UP REPORT WAS SUBMITTED INCORRECTLY; PLEASE REFER TO PR 163563 FOR REPORTING PURPOSES.

    Additional Manufacturer Narrative · 0

    SINCE THERE IS NO DEVICE INFORMATION WAS PROVIDED. THE EXACT RECALL NUMBER IS UNKNOWN. POSSIBLE RECALL NUMBERS INCLUDE Z-1972-2021, Z-1973-2021, AND Z-1974-2021 THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION 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 VISUALIZATION OF PARTICLES IN THE TUBING CHAMBER. ADDITIONAL ALLEGATION INCLUDES SINUS ISSUES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. ON THE PREVIOUSLY SUBMITTED REPORT, THE WRONG TYPE OF REPORTED COMPLAINT WAS SELECTED(MALFUNCTION). IT IS CORRECTED ON THIS REPORT AND UPDATED TO AN SI. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    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 VISUALIZATION OF PARTICLES IN THE TUBING CHAMBER. ADDITIONAL ALLEGATION INCLUDES SINUS ISSUES. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. 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
    914722 NO EQUIPMENT NUMBER VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. 999998

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other