BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFLOW

    MDR report key: 15481133 · Received September 24, 2022

    Report

    Report Number
    3013407532-2022-00002
    Event Type
    Injury
    Date Received
    September 24, 2022
    Date of Event
    August 29, 2022
    Report Date
    August 29, 2022
    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

    AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. A VISUAL INSPECTION SHOWED THAT THE SENSOR HEAD IS BROKEN IN 2 PIECES. THE ULTRASONIC WELD WAS INSPECTED AND FOUND AN INADEQUATE AMOUNT OF BOND THROUGHOUT THE SENSOR HEAD SEAM. A COMBINATION OF PHYSICAL DAMAGE AND A NOT SO THOROUGH ULTRA-SONIC WELD OF THE SENSOR HEAD SEAM CONTRIBUTED TO THE REPORTED ISSUE. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA VENTILATOR TUBE GOT DISCONNECTED FROM ETT (ENDOTRACHEAL TUBE) AND FELL ON FLOOR. THE ADAPTER SECTION IN VENT CIRCUIT WAS COMPLETELY SPLIT. THE PATIENT WAS MANUALLY VENTILATE WITH BAG VALVE MASK. PATIENT WAS DESATURATED TO 64% AND QUICKLY RECOVERED AFTER BAG VALVE MASK VENTILATON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2579468 IFLOW SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS) BZO IMTMEDICAL PTE. LTD. IFLOW 200S PLUS FLOW SENSOR, SINGLE USE 07640149388985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention