BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO

    MDR report key: 19610896 · Received June 25, 2024

    Report

    Report Number
    2518422-2024-39479
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 29, 2024
    Report Date
    June 25, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    Adverse Event
    Yes
    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 LUNG COMPLAINTS OF COPD FROM USING HIS PHILIPS REMSTAR PRO DEVICE. THE USER STATES THAT HE HAS NEVER SMOKED. THE USER STATES HIS DEVICE WAS DEFECTIVE. USER ALLEGES HE USED THE DEVICE FOR FOUR YEARS AND GOT INCREASINGLY SICK. IN THE END, LUNG DAMAGE AND DIAGNOSED WITH COPD. 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
    481534 REMSTAR PRO VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other