BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REP DREAMSTATION AUTO CPAP, JP

    MDR report key: 21927032 · Received April 29, 2025

    Report

    Report Number
    2518422-2025-104894
    Event Type
    Malfunction
    Date Received
    April 29, 2025
    Date of Event
    April 9, 2025
    Report Date
    July 9, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959428539
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. DURING THE EVALUATION, AN EXTERNAL AND INTERNAL VISUAL INSPECTION OF THE DEVICE WAS COMPLETED BY THE MANUFACTURER AND FOUND DUST-LIKE CONTAMINATION AT THE AIR INLET OF THE BLOWER BOX, TOP OF THE BLOWER MOTOR, AND INSIDE OF THE MOTOR. THE MANUFACTURER ALSO FOUND BLACK CONTAMINATION, CONSISTENT WITH KERATIN, AT THE AIR OUTLET OF THE BLOWER BOX, CONSISTENT WITH ER 2243857 V01. THE MANUFACTURER CONFIRMED THE COMPLAINT OF A RATTLING NOISE AND BLACK FRAGMENTS COMING OUT. THE MANUFACTURER CONCLUDES CONTAMINATIONS WERE EXTERNAL TO THE DEVICE.

    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 BLACK FRAGMENTS. THERE IS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. NO MEDICAL INTERVENTION WAS REQUIRED BY THE PATIENT. THE MANUFACTURER'S INVESTIGATION IS ONGOING. 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
    1223188 REP DREAMSTATION AUTO CPAP, JP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. RJPX500S16F 00606959428539

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown