BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PLUS C-FLEX

    MDR report key: 19601392 · Received June 24, 2024

    Report

    Report Number
    2518422-2024-39070
    Event Type
    Injury
    Date Received
    June 24, 2024
    Date of Event
    October 12, 2023
    Report Date
    February 23, 2026
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959015630
    PMA / PMN Number
    K091319
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    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 REPORTER ALLEGED RESPIRATORY TRACT IRRITATION, ASTHMA, INFLAMMATORY RESPONSE, COPD, INFLAMMATION, FLUID BUILD-UP IN LUNGS, CHRONIC BRONCHITIS, ACUTE RESPIRATORY DISTRESS SYSTEM, RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE. THE UPDATED DESCRIBE EVENT OR PROBLEM WILL BE: 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 REPORTER ALLEGED RESPIRATORY TRACT IRRITATION, ASTHMA, INFLAMMATORY RESPONSE, COPD, INFLAMMATION, FLUID BUILD-UP IN LUNGS, CHRONIC BRONCHITIS, ACUTE RESPIRATORY DISTRESS SYSTEM, RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE. THE DEVICE WAS RETURNED TO THE THIRD PARTY SERVICE CENTER FOR EVALUATION. DURING THE EVALUATION, THE DEVICE WAS VISUALLY INSPECTED AND VISIBLE FOAM PARTICLES WERE OBSERVED. ADDITIONALLY, CONTAMINATION WAS ALSO OBSERVED. THE DEVICE WAS SCRAPPED. IN BOX D: PRODUCT UDI, OPERATOR OF DEVICE - OTHER, DEVICE SERVICED BY 3RDP?, DEVICE AVAIL. FOR EVAL? (RFB), DEVICE AVAILABLE FOR EVAL?, DATE RETURNED TO MFG ARE UPDATED IN THIS FOLLOW-UP. IN BOX G: DATE RECEIVED BY MFG IS UPDATED IN THIS FOLLOW-UP. IN BOX H: DEVICE AVAIL. FOR EVAL? (RFB), DEVICE EVALUATED BY MFG?, EVALUATION METHOD CODE GRID, EVALUATION RESULTS CODE GRID, COMPONENT CODE GRID, CONCLUSION CODE GRID ARE UPDATED IN THIS FOLLOW-UP.

    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 REPORTER ALLEGED RESPIRATORY TRACT IRRITATION, ASTHMA, INFLAMMATORY RESPONSE, COPD, INFLAMMATION, FLUID BUILD-UP IN LUNGS, CHRONIC BRONCHITIS, ACUTE RESPIRATORY DISTRESS SYSTEM, RESPIRATORY FAILURE, CONGESTIVE HEART FAILURE. MEDICAL INTERVENTION WAS NOT SPECIFIED. 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
    507671 REMSTAR PLUS C-FLEX VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS250HS 00606959015630

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other