BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION

    MDR report key: 21465437 · Received February 25, 2025

    Report

    Report Number
    2518422-2025-102323
    Event Type
    Malfunction
    Date Received
    February 25, 2025
    Date of Event
    August 29, 2024
    Report Date
    April 11, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424159
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED INFORMATION 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 FOLLOWING SECTIONS WERE CORRECTED: H6. THE PATIENT OUTCOME CODE WAS INITIALLY NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, BUT IS NOW UPDATED TO HEMORRHAGE/BLOOD LOSS/BLEEDING (C26791). THE HEALTH IMPACT CODE WAS INITIALLY NO HEALTH IMPACT, BUT IS NOW UPDATED TO HOSPITALIZATION OR PROLONGED HOSPITALIZATION (C171989). ADDITIONALLY, THE PRODUCT ASSOCIATED WITH THIS COMPLAINT WAS NOT RETURNED TO THE MANUFACTURER. THIS REPORT IS BEING SENT TO CONCLUDE THAT NO FURTHER INVESTIGATION IS POSSIBLE. NO DEVICE HAS BEEN RETURNED. NO FURTHER EVALUATION IS POSSIBLE AT THIS TIME. MULTIPLE ATTEMPTS TO HAVE THE DEVICE RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. IN ADDITION, CAPA PR 7211 DOCUMENTS THE INVESTIGATION INTO SIMILAR COMPLAINTS, CORRECTION/REMOVAL ACTIVITIES HAVE BEEN INITIATED (REFER TO H.9), AND COMPLAINT CODE TRENDING IS REVIEWED ON A PERIODIC BASIS TO EVALUATE FIELD QUALITY PERFORMANCE, AND AS AN INPUT TO RISK MANAGEMENT ACTIVITIES.

    Additional Manufacturer Narrative · 0

    THE SECTION THAT WAS BEING CORRECTED WAS THE HEALTH IMPACT CODE WHICH WAS UPDATED TO NO HEALTH CONSEQUENCES OR IMPACT.

    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. DURING THE EVALUATION OF THE DEVICE, THE THIRD-PARTY SERVICE CENTER VISUALLY INSPECTED THE DEVICE AND FOUND EVIDENCE OF FOAM PARTICLES OR DEGRADATION. THE MANUFACTURER'S INVESTIGATION IS ONGOING. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1027784 DREAMSTATION VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11 00606959424159

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown