BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION BIPAP PRO

    MDR report key: 20625039 · Received November 6, 2024

    Report

    Report Number
    2518422-2024-103428
    Event Type
    Malfunction
    Date Received
    November 6, 2024
    Date of Event
    October 16, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424234
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1972-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    A DEVICE WAS RETURNED TO A THIRD PARTY SERVICE CENTER IN REFERENCE TO THE VOLUNTARY FIELD SAFETY NOTICE / RECALL NOTIFICATION RELATED TO THE SOUND ABATEMENT FOAM IN CERTAIN CPAP, BIPAP, AND MECHANICAL VENTILATOR DEVICES. DURING THE EVALUATION OF THE DEVICE, THE THIRD PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM DEGRADATION. DURING THE EVALUATION, FOAM PARTICLES WERE OBSERVED IN THE BLOWER KIT. ALSO REPORTED ERROR CODES 53, 191, 130. DEVICE HAS BEEN SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1429487 DREAMSTATION BIPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX600S11 00606959424234

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown