BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IFLOW

    MDR report key: 12836993 · Received November 18, 2021

    Report

    Report Number
    3004553423-2021-01268
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    September 30, 2021
    Report Date
    October 21, 2021
    Manufacturer
    IMTMEDICAL PTE. LTD.
    Product Code
    BZO
    UDI-DI
    07640149380767
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. VYAIRE MEDICAL WAS UNABLE TO DETERMINE THE EXACT ROOT CAUSE BUT MOST LIKELY IT IS DUE TO AN IMPROPER/ ROUGH HANDLING BASED ON SIMULATIONS AND BREAK TESTS PERFORMED.

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS SENT TO US FOR EVALUATION BUT WE HAVE NOT RECEIVED IT YET. 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

    THE SUSPECT DEVICE WAS SENT TO US FOR EVALUATION BUT WE HAVE NOT RECEIVED IT YET. 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

    THE CUSTOMER REPORTED BELLAVISTA - IFLOW 200S SENSOR CAME APART WHILE ON A PATIENT. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE PATIENT WAS REMOVED FROM THE VENTILATOR DUE TO PROBLEM BUT NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BELLAVISTA - IFLOW 200S SENSOR CAME APART WHILE ON A PATIENT. FURTHERMORE, THE CUSTOMER CONFIRMED THAT THE PATIENT WAS REMOVED FROM THE VENTILATOR DUE TO PROBLEM BUT NO PATIENT HARM ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737352 IFLOW SET,TUBING AND SUPPORT, VENTILATOR (W/HARNESS) BZO IMTMEDICAL PTE. LTD. IFLOW 200 S ADULT/PEDIATRIC PROXIMAL FLOW SENSOR 4620 07640149380767

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Male Required Intervention