BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DREAMSTATION AUT

    MDR report key: 14047223 · Received April 7, 2022

    Report

    Report Number
    2518422-2022-12719
    Event Type
    Injury
    Date Received
    April 7, 2022
    Date of Event
    March 21, 2022
    Report Date
    August 22, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    RES 88058
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 ABOUT AN ALLEGED LYMPHOMA OF THE LYMPH NODES. THE DEVICE WAS RETURNED TO THE MANUFACTURER'S PRODUCT INVESTIGATION LABORATORY FOR INVESTIGATION. DURING THE INVESTIGATION, THE MANUFACTURER USING A KNOWN GOOD POWER SUPPLY AND POWER CORD AND OBSERVED THE FOLLOWING FROM AN INVESTIGATION. WHITE, GRAY, AND BLACK DUST-LIKE CONTAMINATION AT THE AIR INLET OF THE BLOWER BOX. DUST-LIKE CONTAMINATION ON TOP OF THE BLOWER BOX, THE BLOWER MOTOR, AND THE BLOWER MOTOR SEAL. BLACK DUST-LIKE CONTAMINATION (INCONSISTENT WITH DEGRADED SOUND ABATEMENT FOAM) IN THE BOTTOM OF THE ENCLOSURE, INSIDE OF THE BACK ENCLOSURE, UI PANEL. DUST-LIKE CONTAMINATION ON THE BOTTOM OF THE BLOWER MOTOR AND INSIDE OF THE BLOWER MOTOR, BOTTOM THE BLOWER BOX, INSIDE OF THE OUTLET PORT. SLIGHT BLACK CONTAMINATION, CONSISTENT WITH KERATIN, AT THE AIR OUTLET OF THE BLOWER BOX. THE MANUFACTURER USED A FITT (FOAM INTEGRITY TEST TOOL) WAS NOT ABLE TO CONFIRM THE PRESENCE OF DEGRADED SOUND ABATEMENT FOAM. EVIDENCE OF SOUND ABATEMENT FOAM DEGRADATION/BREAKDOWN WAS NOT OBSERVED. THE DEVICE'S DOWNLOADED EVENT LOG WAS REVIEWED BY THE MANUFACTURER AND FOUND ZERO ERROR. THE MANUFACTURER IS UNABLE TO DIRECTLY ADDRESS THE SYMPTOMS OUTLINED IN THE COMPLAINT, THEY DID OBSERVE DUST/DIRT CONTAMINATION IN THE AIRPATH, LIKELY FROM A SOURCE EXTERNAL TO THE DEVICE AND ALSO OBSERVED NO EVIDENCE OF DEGRADED SOUND ABATEMENT FOAM. IN THIS REPORT, SECTION H6 HAS BEEN UPDATED.

    Description of Event or Problem · 0

    THE MANUFACTURER RECEIVED INFORMATION ALLEGING AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THE PATIENT ALLEGES " LYMPHOMA OF THE LYMPH NODES." THE MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    939316 DREAMSTATION AUT VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. FRX500S14

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other