BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14685540 · Received June 14, 2022

    Report

    Report Number
    2518422-2022-42366
    Event Type
    Malfunction
    Date Received
    June 14, 2022
    Date of Event
    July 23, 2021
    Report Date
    November 19, 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
    MI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON NOV 11, 2022, 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 ALLEGATION ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAVE ALLEGED OF HAVING BARRETT'S ESOPHAGUS AND A COUGH. SECTIONS B1, H1, H6 HAVE BEEN CORRECTED IN THIS REPORT AS FOLLOWS: SECTION B1 WAS CORRECTED FOR PRODUCT PROBLEM (ADVERSE EVENT AND PRODUCT PROBLEM WAS CHECKED IN THE PREVIOUS MDR). SECTION H1 WAS CHANGED FROM SERIOUS INJURY TO MALFUNCTION. SECTION H6 HEALTH EFFECTS - IMPACT CODE WAS CORRECTED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED BARRETT'S ESOPHAGUS AND A COUGH WHILE USING THE DEVICE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    1367191 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Unknown Other