BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 21261709 · Received January 29, 2025

    Report

    Report Number
    2518422-2025-009052
    Event Type
    Malfunction
    Date Received
    January 29, 2025
    Date of Event
    December 31, 2024
    Report Date
    January 9, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005839
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE MANUFACTURER REPORTED ON THIS DEVICE IN MDR 2518422 2025 009052 IN ERROR. AT THIS TIME OF INVESTIGATION, IT HAS BEEN DETERMINED THAT ALL FURTHER REPORTING ACTIVITIES WILL BE CARRIED OUT IN SRC (B)(4). SO, MDR 2518422 2025 009052 IS A DUPLICATE OF SRC (B)(4).

    Additional Manufacturer Narrative · 0

    IN PREVIOUS REPORT, ADDITIONAL NARRATIVE SECTION WAS CAPTURED INCORRECTLY. THE MANUFACTURER PREVIOUSLY REPORTED ON THIS DEVICE IN MDR 2518422-2025-100818. THIS REPORT WAS SUBMITTED AS A DUPLICATE REPORT OF THE PREVIOUSLY SUBMITTED REPORT. CONSIDER THIS CASE AS A DUPLICATE OF MDR 2518422-2025-100818.

    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 VISUALIZATION OF PARTICLES. THERE WAS NO REPORT OF SERIOUS PATIENT HARM OR INJURY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER. AT THIS TIME, NO FURTHER INVESTIGATION CAN BE REQUESTED. IF ANY ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1817965 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS460HS 00606959005839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown