BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR AUTOA-FLE

    MDR report key: 19494148 · Received June 8, 2024

    Report

    Report Number
    2518422-2024-35229
    Event Type
    Injury
    Date Received
    June 8, 2024
    Date of Event
    October 9, 2023
    Report Date
    May 11, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005891
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1972-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 08/08/2024 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 RECEIVED INFORMATION ALLEGING FOLLICULAR LYMPHOMA AT DIAPHRAGM AND CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. REPEATED ATTEMPTS TO HAVE THE DEVICE AND COMPONENTS RETURNED FOR EVALUATION AND INVESTIGATION WERE UNSUCCESSFUL. THE MANUFACTURER BELIEVES THEY WILL BE UNABLE TO GATHER ADDITIONAL INFORMATION. THE MANUFACTURER IS SUBMITTING A FINAL REPORT AT THIS TIME. IF PERTINENT INFORMATION BECOMES AVAILABLE TO THE MANUFACTURER AT A LATER DATE, AN ADDENDUM TO THIS FINAL REPORT WILL BE FILED. BOX H WAS UPDATED IN THIS REPORT.

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2022-58219. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED 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 FOLLICULAR LYMPHOMA AT DIAPHRAGM AND CANCER. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    448937 REMSTAR AUTOA-FLE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS560HS 00606959005891

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening