BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REP DREAMSTATION AUTO

    MDR report key: 21810447 · Received April 9, 2025

    Report

    Report Number
    2518422-2025-103909
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    April 3, 2025
    Report Date
    April 7, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959429772
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED 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 SHORTNESS OF BREATH. THE PATIENT HAS BEEN SEEN BY A PULMONOLOGIST AND A CARDIOLOGIST. MEDICAL INTERVENTION INCLUDED SPIROMETRY, 6-MINUTE WALK TEST, AND CHEST CT SCAN. THE PATIENT REQUIRED UNKNOWN CARDIAC PRESCRIPTION MEDICATIONS. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE. THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER. THIS REPORT IS BEING SENT TO CONCLUDE THAT NO FURTHER INVESTIGATION IS POSSIBLE. NO DEVICE HAS BEEN RETURNED. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. MULTIPLE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. IN ADDITION, CAPA PR 7211 DOCUMENTS THE INVESTIGATION INTO SIMILAR COMPLAINTS, CORRECTION/REMOVAL ACTIVITIES HAVE BEEN INITIATED (REFER TO H9), AND COMPLAINT CODE TRENDING IS REVIEWED ON A PERIODIC BASIS TO EVALUATE FIELD QUALITY PERFORMANCE, AND AS AN INPUT TO RISK MANAGEMENT ACTIVITIES.

    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 SHORTNESS OF BREATH. THE PATIENT HAS BEEN SEEN BY A PULMONOLOGIST AND A CARDIOLOGIST. MEDICAL INTERVENTION INCLUDED SPIROMETRY, 6-MINUTE WALK TEST, AND CHEST CT SCAN. THE PATIENT REQUIRED UNKNOWN CARDIAC PRESCRIPTION MEDICATIONS. 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
    1454617 REP DREAMSTATION AUTO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. UDSX700S11F 00606959429772

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Required Intervention