BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REMSTAR PLUS C-FLEX

    MDR report key: 19760435 · Received July 17, 2024

    Report

    Report Number
    2518422-2024-44920
    Event Type
    Malfunction
    Date Received
    July 17, 2024
    Date of Event
    June 29, 2024
    Report Date
    July 17, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE PREVIOUSLY SUBMITTED REPORT 510K NUMBER OF SECTION G WAS INCORRECT. IN THIS REPORT, 510K NUMBER OF SECTION G HAS BEEN CORRECTED/UPDATED AS K091319.

    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 AN ISSUE RELATED TO A CPAP DEVICE'S SOUND ABATEMENT FOAM. THERE WAS NO ALLEGATION OF SERIOUS OR PERMANENT HARM OR INJURY. THE DEVICE WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR FURTHER EVALUATION. DURING EVALUATION OF THE DEVICE AT A THIRD-PARTY SERVICE CENTER, THE DEVICE LOGS WERE DOWNLOADED AND ERRORS CODE WERE FOUND. THERE WAS EVIDENCE OF FOAM PARTICLES DURING THE TESTING OF THE DEVICE. THE SERVICE CENTER ALSO FOUND DUST AND DIRT INSIDE THE DEVICE. THE DEVICE WAS SCRAPPED AS PER CUSTOMER REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    719357 REMSTAR PLUS C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. IN251S

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown