BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15251511 · Received August 18, 2022

    Report

    Report Number
    2518422-2022-72310
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    November 19, 2021
    Report Date
    August 20, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 30, 2024, AND SECTION H10 SHOULD BE REPORTED AS: 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PAYIENT ALLEGED CHRONIC SINUS INFECTION, HEART DISEASE. MEDICAL INTERVENTION WAS NOT SPECIFIED. ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE ALLEGED LARYNGEAL CANCER. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, OBSERVED AN UNKNOWN DUST CONTAMINANT ON THE TOP ENCLOSURE, FRONT PANEL, REAR PANEL, BOTTOM ENCLOSURE, BLOWER, BLOWER SEAL, AND BLOWER BOX. EVIDENCE OF LIQUID INGRESS WAS OBSERVED ON THE BLOWER AND BLOWER BOX. A KERATIN-LIKE SUBSTANCE WAS OBSERVED ON THE BLOWER BOX OUTLET. VIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE NO ERRORS FOUND. IN THIS REPORT, SECTIONS D9, G3, H3, AND H6 HAVE BEEN UPDATED.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 04, 2024, AND SECTION H11 SHOULD BE REPORTED AS: 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 PREVIOUSLY RECEIVED INFORMATION ALLEGING SINUS INFECTION AND HEART DISEASE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. ADDITIONAL INFORMATION WAS RECEIVED ABOUT THE ALLEGED LARYNGEAL CANCER. SECTION E1 WAS UPDATED IN THIS REPORT. SECTION H6 HEALTH EFFECTS: CLINICAL CODES WERE UPDATED.

    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, AND MECHANICAL VENTILATOR DEVICES. THE MANUFACTURER RECEIVED INFORMATION ALLEGING CHRONIC SINUS INFECTION, HEART DISEASE. 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
    2089954 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other