BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 15680151 · Received October 27, 2022

    Report

    Report Number
    2518422-2022-88385
    Event Type
    Malfunction
    Date Received
    October 27, 2022
    Date of Event
    October 24, 2022
    Report Date
    September 6, 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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUS FOLLOW-UP REPORT (MDR 2518422-2022-88385-1), SECTION H6 WAS INCORRECTLY CAPTURED, IT HAS BEEN CORRECTED IN THIS REPORT TO REFLECT THE CORRECT INFORMATION.

    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 WAS 01 ERRORS FOUND. THE MANUFACTURER CONCLUDES THAT THEY COULD NOT CONFIRM THE CUSTOMER'S ALLEGATION AND THERE WAS NO VISIBLE FOAM DEGRADATION. SECTION H6 UPDATED IN THIS 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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT HAS ALLEGED VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. 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
    2480544 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS,INC DSX500T11C

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown