BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21978874 · Received May 7, 2025

    Report

    Report Number
    2518422-2025-105307
    Event Type
    Injury
    Date Received
    May 7, 2025
    Date of Event
    May 2, 2025
    Report Date
    May 14, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959424173
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    FURTHER REVIEW SINCE THE DISCOVERY OF THE DEVICE INFORMATION REVEALED THAT THIS ISSUE HAS ALREADY BEEN REPORTED ON 08SEP2021 MDR 2518422-2021-03311-1, 07NOV2025 MDR 2518422-2021-03311-2, 11NOV2025 MDR 2518422-2021-03311-3. THIS REPORT IS BEING CLOSED AS A DUPLICATE.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS SUBMITTED TO PROVIDE ADDITIONAL INFORMATION FROM THE MANUFACTURER'S FINAL INVESTIGATION FINDINGS AND TO INCLUDE THE RELATED CODING FIELDS AND DATE RECEIVED BY MFG. THE MANUFACTURER PREVIOUSLY REPORTED: "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 THAT THE DREAMSTATION AUTO CPAP DEVICE HAD FOAM ISSUES, AND BLACK ARTICLES WERE REPORTED IN THE NASAL PILLOW, TUBE, AND WATER TANK WHILE IN USE. IN ADDITION, THE PATIENT ALLEGEDLY HAD SURGERY ON HIS SINUSES AND SEPSIS, WHICH CAUSED RENAL FAILURE. THE DME GAVE HIM A FILTER TO ATTACH TO THE HOSE TO CATCH PARTICLES. THE PATIENT STATED THEY FOUND 2 TYPES OF CYSTS, AND THEY WERE BENIGN. THE ENT DOCTOR FOUND THE CYSTS AND HAD THE SECOND SURGERY IN 2025. THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE." 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.

    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 THAT THE DREAMSTATION AUTO CPAP DEVICE HAD FOAM ISSUES, AND BLACK ARTICLES WERE REPORTED IN THE NASAL PILLOW, TUBE, AND WATER TANK WHILE IN USE. IN ADDITION, THE PATIENT ALLEGEDLY HAD SURGERY ON HIS SINUSES AND SEPSIS, WHICH CAUSED RENAL FAILURE. THE DME GAVE HIM A FILTER TO ATTACH TO THE HOSE TO CATCH PARTICLES. THE PATIENT STATED THEY FOUND 2 TYPES OF CYSTS, AND THEY WERE BENIGN. THE ENT DOCTOR FOUND THE CYSTS AND HAD THE SECOND SURGERY IN 2025. THE MANUFACTURER'S INVESTIGATION IS ONGOING. THE DEVICE HAS NOT YET BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. 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
    249743 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500S11 00606959424173

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Male Life Threatening| R