BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 24573268 · Received March 11, 2026

    Report

    Report Number
    2518422-2026-108739
    Event Type
    Malfunction
    Date Received
    March 11, 2026
    Date of Event
    November 4, 2022
    Report Date
    March 18, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959051515
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    505

    Narratives

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORT, BOX H: : MANUFACTURE DATE (RFB) WAS CAPTURED INCORRECTLY AS 11/16/2028, WHICH HAS BEEN CORRECTED IN THIS REPORT AS: 11/16/2018.

    Additional Manufacturer Narrative · 0

    THE CAPA PROCESS IDENTIFIED COMPLAINTS NOT BEING CREATED FOR QUALITY ISSUES FOUND DURING THIRD PARTY SERVICING. BASED ON A REVIEW OF RECORDS IMPACTED BY THE IDENTIFIED ISSUE, IT WAS DETERMINED THAT THIS RECORD NEEDED TO BE CORRECTED AND IS NOW BEING SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    A DEVICE WAS RETURNED TO 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 AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF FOAM DEGRADATION. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE THIRD-PARTY SERVICE CENTER. SECONDARY FINDINGS OBSERVED. THERE WERE NO ERROR CODES FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRMED THE CUSTOMER'S ALLEGATION AND THERE WAS A VISIBLE FOAM DEGRADATION AND UNIT GOT CORRECTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    635480 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C 00606959051515

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown