BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 21794858 · Received April 8, 2025

    Report

    Report Number
    2518422-2025-041810
    Event Type
    Malfunction
    Date Received
    April 8, 2025
    Date of Event
    July 15, 2022
    Report Date
    May 7, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    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 ON THIS DEVICE IN MDR TW 5467308 2518422-2024-072564. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT.

    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 VISUALIZATION OF PARTICLES RELATED TO CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING THE EVALUATION OF THE DEVICE AT THE THIRD-PARTY SERVICE CENTER, THE DEVICE WAS VISUALLY INSPECTED AND FOUND EVIDENCE OF VISIBLE FOAM PARTICLES. DURING THE EVALUATION, SECONDARY FINDINGS WAS OBSERVED. THERE WAS NO ERROR CODE FOUND. THE THIRD-PARTY SERVICE CENTER CONCLUDES THAT THEY CONFIRM THE CUSTOMER'S ALLEGATION AND UNIT CORRECTED. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    490618 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown