BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 17565899 · Received August 17, 2023

    Report

    Report Number
    2518422-2023-20060
    Event Type
    Malfunction
    Date Received
    August 17, 2023
    Date of Event
    August 25, 2021
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    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 PATIENT ALLEGES "HEADACHE, SORE THROAT, COUGHING, LOSS OF VOICE AND TICKLING IN THROAT". THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS SPECIFIED AS REQUIRED BY THE PATIENT. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. AN EXTERNAL AND INTERNAL VISUAL INSPECTION OF DEVICE WERE COMPLETED BY THE MANUFACTURER AND FOUND NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION. THE SOFTWARE UPGRADED, CLEARED ERROR LOG AND RECERTIFIED DEVICE PER FC: (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1665194 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown