BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP AUTOSV

    MDR report key: 16247939 · Received January 26, 2023

    Report

    Report Number
    2518422-2023-02947
    Event Type
    Malfunction
    Date Received
    January 26, 2023
    Date of Event
    January 13, 2023
    Report Date
    June 30, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    MNS
    UDI-DI
    00606959063365
    PMA / PMN Number
    K090539
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    AS PER ADDITIONAL INFORMATION RECEIVED ON 06/24/2025: THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE AIRFLOW WAS VERIFIED TO BE OPERATING CORRECTLY. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND 0 ERRORS. AN INTERNAL AND EXTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER AND FOUND THERAPY BUTTON COVER WAS DAMAGED BUT STILL FUNCTIONED, UNKNOWN WHITE CONTAMINATION (DUST-LIKE) AT THE AIR INLET, ON USER INTERFACE PANEL , LIGHT WHITE DUST-LIKE CONTAMINATION ON TOP OF THE BLOWER BOX, INSIDE OF THE ENCLOSURE, ON TOP OF THE BLOWER MOTOR, BLOWER MOTOR SEAL, BLOWER MOTOR ISOLATORS, INSIDE OF THE BLOWER MOTOR, AND THROUGHOUT THE BLOWER BOX. POTENTIAL MINERAL DEPOSIT SPOTS ON THE BOTTOM OF THE BLOWER MOTOR, ON THE BOTTOM OF THE BLOWER BOX, ON INTERIOR AIR OUTLET PORT INDICATING POTENTIAL WATER INGRESS. AN UNKNOWN CONTAMINATION ON EXTERIOR AIR OUTLET PORT. PIL USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. THERE WERE NO VISIBLE DAMAGE OR FUNCTIONALITY FAILURES OF THE DEVICE, WHICH SUGGESTS THAT THE SOURCE OF CONTAMINATION WAS EXTERNAL TO THE DEVICE. PIL WAS ABLE TO CONFIRM WHITE PARTICLES IN THE AIRWAY, BUT THEY WERE INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM. UDI RELATED DATA QUALITY UPDATES ONLY. THE UDI IN SECTION D4 WAS PREVIOUSLY REPORTED IN THE INCORRECT FORMAT. THE UDI INFORMATION HAS BEEN UPDATED TO THE CORRECT FORMAT. IN THIS REPORT, BOX D, H HAS BEEN UPDATED/CORRECTED.

    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 AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT PATIENT HARM OR INJURY. 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
    770357 DREAMSTATION BIPAP AUTOSV VENTILATOR, CONTINUOUS, NON-LIFE-SUPPORTING MNS RESPIRONICS, INC. DSX900H11C 00606959063365

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown