BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFLOW

    MDR report key: 8972854 · Received September 6, 2019

    Report

    Report Number
    3013407532-2019-00002
    Event Type
    Malfunction
    Date Received
    September 6, 2019
    Date of Event
    March 29, 2019
    Report Date
    March 29, 2019
    Manufacturer
    IMTMEDICAL PTE. LTD.
    Product Code
    BZO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE VYAIRE TECHNICAL SUPPORT EVALUATED THE DEVICE AND FOUND OUT THAT THE LUER PORTS HAVE BROKEN OFF DUE TO A TOO HIGH MECHANICAL FORCE ADDED TO THE PORT. THE ROOT CAUSE HAS BEEN DETERMINED AS USER FAULT DUE TO ROUGH HANDLING.

    Additional Manufacturer Narrative · 1

    ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE SUSPECTED DEVICE'S ACCESSORY WAS BEING USED FOR SEVERAL DAYS UNTIL THE REPORTED ISSUE OCCURRED. ROUGH HANDLING IS NOT AN ISSUE AFTER REPLACEMENT OF THE FLOW SENSOR. AT THIS TIME, THERE IS NO INFORMATION REGARDING THE LOG FILES OF THE DEVICE. THE FLOW SENSOR IS STILL UNDER INVESTIGATION. THEREFORE, NO DEFINITIVE ROOT CAUSE CAN BE DETERMINED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED DEFECTIVE/BROKEN FLOW SENSORS. THE DEVICE WAS ALARMING WITH "TIDAL VOLUME HIGH" WHILE PATIENT WAS STABLE. A WHISTLING NOISE WAS HEARD AND THE BREAKLINE WAS IDENTIFIED AT THE FLOW SENSOR. THE VENTILATION CONTINUE WORKING AS INTENDED WITH NO FURTHER ALARM. THE END USER SUCCESSFULLY REPLACED THE FLOW SENSOR DURING VENTILATION ON A PATIENT. THE ISSUE RESOLVED AFTERWARDS. THERE IS NO PATIENT HARM WITH THIS REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765823 IFLOW SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) BZO IMTMEDICAL PTE. LTD. IFLOW 40 S PROXIMAL FLOW SENSOR 4118

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention