BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION CPAP PRO

    MDR report key: 24332498 · Received February 13, 2026

    Report

    Report Number
    8030978-2026-100000
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    March 1, 2024
    Report Date
    May 6, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959428232
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE FOLLOWING CORRECTION HAS BEEN UPDATED IN THIS REPORT. SECTION "CFN/FEI", CFN NUMBER SHOULD HAVE BEEN 2518422. PLEASE DISREGARD MDR 8030978-2026-100000 AND ALL REPORTING INFORMATION TO BE CARRIED OUT IN PR 7253031 MDR 2518422-2026-112933.

    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 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 AT THE THIRD PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. THE DEVICE WAS SCRAPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206931 DREAMSTATION CPAP PRO VENTILATOR, NON-CONTINUOUS (RESPIR ATOR) BZD RESPIRONICS, INC. LAX400H15 00606959428232

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown