BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO

    MDR report key: 19611128 · Received June 25, 2024

    Report

    Report Number
    2518422-2024-39596
    Event Type
    Malfunction
    Date Received
    June 25, 2024
    Date of Event
    May 31, 2024
    Report Date
    June 25, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DUE TO NO DEVICE INFORMATION, THE POSSIBILITY OF RECALL Z NUMBERS WOULD BE ONE OF THE FOLLOWING: Z-1972-2021, Z-1973-2021 OR Z-1974-2021.

    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 FATIGUE FROM USING HER REMSTAR PRO DEVICE. THE USER STATES SHE USED THIS DEVICE FROM JANUARY OF 2013 UNTIL OCTOBER OF 2017. THE USER STATES THAT SHE RECEIVED A NEW DEVICE FROM HER DISTRIBUTOR IN FEBRUARY 2023. 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 PERFORMED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    578878 REMSTAR PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female