BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REMSTAR PRO C-FLEX+

    MDR report key: 20032349 · Received August 22, 2024

    Report

    Report Number
    2518422-2024-52710
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    August 25, 2024
    Manufacturer
    RESPIRONICS, INC.
    Product Code
    BZD
    UDI-DI
    00606959005839
    PMA / PMN Number
    K131982
    Removal / Correction Number
    Z-1974-2021
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE ABOVE MDR & TW REPORT (TW (B)(4) 2518422-2024-52710) IS DONE BY MISTAKE, PLEASE DISREGARD THE ABOVE REPORT. THE CORRECT REPORT WILL BE THE INITIAL FIRST REPORT (TW (B)(4) 2518422-2024-48611). BOX B (DEVICE NAME) IS UPDATED IN THIS REPORT.

    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 NOSE IRRITATION,RESPIRATORY TRACT IRRITATION,DIZZINESS,ASTHMA,INFLAMMATORY RESPONSE,LUNG DISEASE. NO OTHER CLINICAL INFORMATION OR MEDICAL INTERVENTIONS WERE REPORTED. THE MANUFACTURER'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    940993 REMSTAR PRO C-FLEX+ VENTILATOR, NON-CONTINUOUS (RESPIRATOR) BZD RESPIRONICS, INC. DS460HS 00606959005839

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other