BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IFLOW

    MDR report key: 15419697 · Received September 14, 2022

    Report

    Report Number
    3013407532-2022-00001
    Event Type
    Malfunction
    Date Received
    September 14, 2022
    Date of Event
    April 8, 2022
    Report Date
    August 18, 2022
    Manufacturer
    IMTMEDICAL PTE. LTD.
    Product Code
    BZO
    UDI-DI
    07640149381344
    PMA / PMN Number
    K163127
    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

    RESULT OF INVESTIGATION: EXACT ISSUE IS NOT CLEAR AS NO UPDATE RECEIVED FROM CUSTOMER. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA-IFLOW SENSOR TUBING FELL ON THE FLOOR WITH PIECE ATTACHED AND IT BROKE INTO TWO SEPARATE PIECES CLEANLY.THE ISSUE OCCURRED DURING PATIENT-USE AND AT THIS TIME, THE CUSTOMER HAS NOT PROVIDED ANY INFORMATION REGARDING PATIENT HARM OR INJURY ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2746610 IFLOW SET, TUBING AND SUPPORT, VENTILATOR (W HARNESS) BZO IMTMEDICAL PTE. LTD. IFLOW 200 S ADULT/PEDIATRIC PROXIMAL FLOW SENSOR 07640149381344

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Female