BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO C-FLE

    MDR report key: 19614844 · Received June 26, 2024

    Report

    Report Number
    2518422-2024-39736
    Event Type
    Injury
    Date Received
    June 26, 2024
    Date of Event
    October 9, 2023
    Report Date
    June 26, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005839
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    THE MANUFACTURER WAS CONTACTED ABOUT 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 ABOUT AN ALLEGATION OF UNSPECIFIED CANCER. THERE WAS NO REPORT OF SPECIFIC MEDICAL INTERVENTIONS. NO ADDITIONAL INFORMATION CAN BE REQUESTED AT THIS TIME. THE MANUFACTURER WAS MADE AWARE OF THIS COMPLAINT THROUGH A REPRESENTATIVE OF THE CUSTOMER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE CARRIED OUT. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    624739 REMSTAR PRO C-FLE VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS460HS 00606959005839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other