BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUNMED LLC

    MDR report key: 16114398 · Received January 6, 2023

    Report

    Report Number
    1314417-2023-00001
    Event Type
    Injury
    Date Received
    January 6, 2023
    Date of Event
    December 5, 2022
    Report Date
    January 6, 2023
    Manufacturer
    SUNMED LLC
    Product Code
    BTM
    UDI-DI
    10889483103012
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VENTILATION WAS COMPROMISED AND THE PATIENT WAS DEEMED HYPOXIC. THE BVM MALFUNCTIONING WOULD POTENTIALLY LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET.

    Additional Manufacturer Narrative · 0

    VENTILATION WAS COMPROMISED AND THE PATIENT WAS DEEMED HYPOXIC. THE BVM MALFUNCTIONING WOULD POTENTIALLY LOWER THE VOLUME DELIVERED TO THE PATIENT. BASED ON THE REPORTED INFORMATION, THE CRITERIA FOR REPORTING AN ADVERSE EVENT HAVE BEEN MET SUMMARY: RETURNED PRODUCT CONFIRMS COMPLAINT. PRODUCT WAS FOUND TO BE MISSING A DUCKBILL VALVE WHICH PREVENTED ANY PRESSURE TO BE DELIVERED TO THE PATIENT PORT. CUSTOMER NOTIFIED OF DEFECT, MITIGATION PROCESS OUTLINED IN IFU, AND DEFECT RATES. RA: RISK ASSESSMENT REVIEW OF RMA-20020, R37 IDENTIFIES THAT MISSING COMPONENTS (LIKE THE TAIL ASSEMBLY UMBRELLA VALVE) ARE ASSOCIATED WITH A SEVERITY OF 7.

    Description of Event or Problem · 0

    PATIENT DISCONNECTED FROM THE VENTILATOR AND PLACED ON AMBU BAG BY ANESTHESIA RESIDENT TEAM. PATIENT MOVED OUT OF OPERATING ROOM AND DOWN H HALLWAYS TO TRANSFER TO ICU. BETWEEN H AND G IT WAS NOTED THE PATIENT WAS DESATURATING AND THE VITAL SIGNS WERE BEGINNING TO DECOMPENSATE. AT THIS TIME, IT WAS NOTED THE AMBU BAG WAS NOT VENTILATING THE PATIENT. ALL CONNECTION AND OXYGEN SUPPLY WERE VERIFIED AND CHECKED. A RESIDENT RAN TO THE OPERATING ROOM TO GET A NEW AMBU BAG AND THE TEAM RUSHED THE PATIENT BACK INTO THE OPERATING ROOM. THE NEW AMBU BAG APPEARED TO FUNCTIONING PROPERLY. VENTILATION WAS VERIFIED BY AUSCULTATION AND HE WAS VENTILATED UNTIL OXYGEN SATURATIONS IMPROVED. THE PATIENT WAS THEN TRANSFERRED TO THE ICU WITHOUT ISSUE.

    Description of Event or Problem · 0

    PATIENT DISCONNECTED FROM THE VENTILATOR AND PLACED ON AMBU BAG BY ANESTHESIA RESIDENT TEAM. PATIENT MOVED OUT OF OR AND DOWN H HALLWAYS TO TRANSFER TO ICU. BETWEEN H AND G IT WAS NOTED THE PATIENT WAS DESATURATING AND THE VITAL SIGNS WERE BEGINNING TO DECOMPENSATE. AT THIS TIME, IT WAS NOTED THE AMBU BAG WAS NOT VENTILATING THE PATIENT. ALL CONNECTION AND OXYGEN SUPPLY WERE VERIFIED AND CHECKED. A RESIDENT RAN TO THE OR TO GET A NEW AMBU BAG AND THE TEAM RUSHED THE PATIENT BACK INTO THE OR. THE NEW AMBU BAG APPEARED TO FUNCTIONING PROPERLY. VENTILATION WAS VERIFIED BY AUSCULTATION AND HE WAS VENTILATED UNTIL OXYGEN SATURATIONS IMPROVED. THE PATIENT WAS THEN TRANSFERRED TO THE ICU WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    574440 SUNMED LLC SMALL ADULT AIRFLOW W/MANOMETER BTM SUNMED LLC AF5140MB UNKNOWN 10889483103012

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other