BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFLOW

    MDR report key: 16191539 · Received January 18, 2023

    Report

    Report Number
    3013407532-2023-00003
    Event Type
    Injury
    Date Received
    January 18, 2023
    Date of Event
    December 27, 2022
    Report Date
    January 17, 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

    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

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO CONFIRM THE ISSUE. THE VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. VISUAL INSPECTION OF THE FLOW SENSOR REVEALED THAT IT HAD SEPARATED AT THE CENTER SEAM. IT HAS BEEN DETERMINED THAT THE FLOW SENSOR WAS NOT SUFFICIENTLY ULTRASONICALLY WELDED DURING MANUFACTURING. THE ROOT CAUSE OF FAILURE WAS DETERMINED TO BE BREAKAGE CAUSED BY INSUFFICIENT ULTRASONIC WELD DURING MANUFACTURING. DESPITE A THOROUGH INVESTIGATION OF SEVERAL RETURNED DEFECTIVE PARTS FROM THE FIELD IN I-CH-20-032, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. THERE WERE NO INDICATIONS OF AN ISSUE WITH THE ULTRASONIC WELDING JOINT, A BATCH PROBLEM, OR ANYTHING ELSE. BASED ON SIMULATIONS AND BREAK TESTS CONDUCTED DURING THE INVESTIGATION, THE MOST LIKELY ROOT CAUSE IS IMPROPER / ROUGH HANDLING. THE DECISION WAS MADE NOT TO PURSUE FURTHER INVESTIGATION BECAUSE THE FAILURE RATE IS EXTREMELY LOW. 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

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 HAD A CRACKED FLOW SENSOR DURING PATIENT USE. FURTHERMORE, THE PATIENT WAS INTUBATED AND SEDATED ON AN ACVC VENTILATOR. THE IFLOW 200S ADULT PROXIMAL FLOW SENSOR SNAPPED WHILE THE PATIENT WAS BEING TURNED FOR CLEANING BY NURSING STAFF, RESULTING IN A DISCONNECT BETWEEN THE PATIENT'S ET TUBE AND THE VENTILATOR. THE PATIENT'S SPO2 BEGAN TO FALL, AND WAS NOT TAKING SPONTANEOUS BREATHS DUE TO SEDATION; THE PATIENT NEEDED TO BE BAG-MASK-VENTILATED FOR 3-4 MINUTES BEFORE THE TUBING WAS REPLACED BY RT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    976993 IFLOW SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS) BZO IMTMEDICAL PTE. LTD. IFLOW 200S PLUS FLOW SENSOR, SINGLE USE 3922A 07640149388985

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown