BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFLOW

    MDR report key: 16244972 · Received January 25, 2023

    Report

    Report Number
    3004553423-2023-01748
    Event Type
    Injury
    Date Received
    January 25, 2023
    Date of Event
    December 6, 2022
    Report Date
    January 25, 2023
    Manufacturer
    IMTMEDICAL PTE. LTD.
    Product Code
    BZO
    UDI-DI
    07640149388985
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CUSTOMER REPORTED THAT THEY ARE NOT SURE IF THEY WILL RETURN THE DEFECTIVE UNIT/PART FOR EVALUATION. THEY DO NOT HAVE THE DEVICE, AND NOT SURE IF IT WAS RETAINED. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH IFLOW 200S PLUS FLOW SENSOR WHERE PATIENT WAS BEING TURNED IN THE PROCESS OF PERSONAL CARE, THE DEVICE SNAPPED AND CAUSED THE PATIENT'S ET (ENDOTRACHEAL) TUBE TO BECOME DISCONNECTED FROM THE VENTILATOR. FURTHERMORE, THERE WAS NO HARM DUE TO THE SWIFT REACTION OF STAFF TO BAG THE PATIENT UNTIL DEVICE COULD BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1109809 IFLOW SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) BZO IMTMEDICAL PTE. LTD. IFLOW 200 S ADULT/PEDIATRIC PROXIMAL FLOW SENSOR 07640149388985

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male Required Intervention