BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 17964530 · Received October 19, 2023

    Report

    Report Number
    2518422-2023-26916
    Event Type
    Malfunction
    Date Received
    October 19, 2023
    Date of Event
    September 9, 2022
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3 OTHER TEXT : DEVICE EVALUATED BY THIRD PARTY SERVICE CENTER.

    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 ALLEGED INTERMITTENT AIRFLOW. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE PATIENT'S DEVICE WAS RETURNED TO THE MANUFACTURER AND WAS SHIPPED TO A THIRD- PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION OF THE DEVICE, THE THIRD- PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING EVALUATION THERE WERE ALSO TECHNICAL FINDINGS OF SCRATCH BY AMBIANCE LIGHT. THE TOP ENCLOSURE WAS REPLACED. THE DEVICE OPERATING SOFTWARE WAS UPGRADED. THE DEVICE PASSED A FINAL TEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2054682 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown