BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP W/HUM/CELL, CAN

    MDR report key: 21330230 · Received February 7, 2025

    Report

    Report Number
    2518422-2025-101826
    Event Type
    Malfunction
    Date Received
    February 7, 2025
    Date of Event
    January 16, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959426986
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A DREAMSTATION AUTO CPAP W/HUM/CELL, CAN DEVICE WAS RETURNED TO A THIRD-PARTY SERVICE CENTER ABOUT THE VOLUNTARY FIELD SAFETY NOTICE/RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. THERE WERE NO REPORTS OF SERIOUS INJURY OR PATIENT HARM, AND THERE WAS NO REPORT OF MEDICAL INTERVENTION. DURING THE EVALUATION, THE SERVICE CENTER VISUALLY INSPECTED THE DEVICE. ERROR CODES #130, #153, AD #200 WERE PRESENT. EVIDENCE OF FOAM DEGRADATION WAS FOUND INSIDE THE ASSEMBLY. THE DEVICE WAS ULTIMATELY SCRAPPED. FURTHER INVESTIGATION CANNOT TAKE PLACE AT THIS TIME. IF NEW INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918627 DREAMSTATION AUTO CPAP W/HUM/CELL, CAN VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. CAX500H12C 00606959426986

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown