BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DREAMSTATION AUTO CPAP

    MDR report key: 14805871 · Received June 24, 2022

    Report

    Report Number
    2518422-2022-39616
    Event Type
    Malfunction
    Date Received
    June 24, 2022
    Date of Event
    July 1, 2017
    Report Date
    August 27, 2024
    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

    ADDITIONAL INFORMATION WAS RECEIVED, AND SECTION H11 SHOULD BE REPORTED AS: 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 RECEIVED VOLUNTRY MEDWATCH (MW 5109848) INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGED COUGH AND BURNING IN THE THROAT AND ALLEGEDLY HAD MOLD IN THE MACHINE. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING INVESTIGATION, THERE IS CONTAMINATION ON THE BLOWER BOX, BLOWER, BLOWER SEAL, AND ON THE UI PANEL. KERATIN-LIKE CONTAMINATION WAS OBSERVED AROUND THE BLOWER OUTPUT SEAL. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) AND WAS ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. 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 A EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION RESIDUE IN THE BLOWER BOX. THE MANUFACTURER NOT ABLE TO CONFIRM THE COMPLAINT OF MOLD AND ADDRESS THE SYMTOMS SPECIFIED. IN THIS REPORT, SECTION H6 HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED A VOLUNTARY MEDWATCH (MW5109848) ALLEGING A CONTINUOUS POSITIVE AIRWAY PRESSURE (CPAP) DEVICE'S SOUND ABATEMENT FOAM BECAME DEGRADED AND CAUSED THE PATIENT COUGH AND BURNING IN THE THROAT. THERE WAS NO REPORT OF SERIOUS OR PERMANENT 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
    635664 DREAMSTATION AUTO CPAP VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC DSX500T11

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown