BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 19612815 · Received June 26, 2024

    Report

    Report Number
    2518422-2024-39603
    Event Type
    Malfunction
    Date Received
    June 26, 2024
    Date of Event
    May 31, 2024
    Report Date
    April 8, 2025
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER WAS PREVIOUSLY 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 (B)(6) 2017 UNTIL (B)(6) 2023. THE USER STATES THAT SHE RECEIVED A NEW DEVICE FROM HER DISTRIBUTOR IN FEBRUARY 2023. THIS INCIDENT REPORT IS RELATED TO THE INVESTIGATION OF THE REMSTAR PRO DEVICE USED BY THE PATIENT FROM (B)(6) 2017 UNTIL (B)(6) 2023. THE DEVICE WAS RETURNED TO THE THIRD-PARTY SERVICE CENTER FOR EVALUATION. DURING SERVICING OF THE DEVICE, DUST/DIRT CONTAMINATION WAS FOUND. THERE WAS NO EVIDENCE OF FOAM DEGRADATION. THE DEVICE HAS BEEN SCRAPPED. SECTION D1, D4, G2, G4, H4, H6 AND H9 HAVE BEEN UPDATED IN THIS FOLLOW-UP REPORT.

    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 OCTOBER 2017 UNTIL FEBRUARY OF 2023. 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
    674321 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN461HS

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female