BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 13453437 · Received February 4, 2022

    Report

    Report Number
    2518422-2022-03244
    Event Type
    Malfunction
    Date Received
    February 4, 2022
    Date of Event
    January 5, 2022
    Report Date
    April 28, 2023
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 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 PREVIOUSLY REPORTED AN ALLEGATION OF AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE MANUFACTURER RECEIVED INFORMATION ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S SERVICE CENTER FOR FURTHER EVALUATION. THE DEVICE WAS EVALUATED. THERE WAS NO MENTION OF VISUAL FINDINGS TO THE EXTERNAL PART OF THE DEVICE. THE INTERNAL ASPECT OF THE DEVICE WAS INSPECTED. THE DEVICE POWERED ON AND AIRFLOW WAS CONFIRMED. THE DEVICE'S DOWNLOADED LOGS WERE REVIEWED BY THE MANUFACTURER. THERE WERE 11 ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED THIS DEVICE ON MDR 2518422-2022-03244-2. PLEASE DISREGARD MDR 2518422-2022-03244-2 AS IT WAS FILED IN ERROR.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A BIPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S QUALITY PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. THE MANUFACTURER VISUALLY INSPECTED THE EXTERNAL PART OF THE DEVICE AND THERE WERE NO SIGNS OF CONTAMINATION ON THE OUTSIDE OF THE DEVICE. THE MANUFACTURER VISUALLY INSPECTED THE DEVICE INTERNALLY AND FOUND UNKNOWN DUST CONTAMINATE IN THE BLOWER BOX AND ON THE FILTER PORT. THE DEVICE'S EVENT LOGS WERE DOWNLOADED AND REVIEWED BY MANUFACTURER. THE MANUFACTURER FOUND NO ERROR CODES.THE MANUFACTURER APPLIED POWER TO THE DEVICE AND VERIFIED AIRFLOW. THE MANUFACTURER CONCLUDES THERE WAS NO EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION, BUT DUST CONTAMINATION WAS OBSERVED AND ARE CONSISTENT WITH BEING FROM AN EXTERNAL SOURCE. SECTION H6 WERE UPDATED IN THIS REPORT.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED TO SEEING PARTICLES. THERE WAS NO REPORT OF PATIENT HARM OR INJURY. THIS ISSUE WAS REPORTED TO THE FDA PER 21 CFR 806. THE DEVICE WILL BE CORRECTED PER RES 88058.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1385895 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DSX500H11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown