BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

    MDR report key: 19041507 · Received April 4, 2024

    Report

    Report Number
    2021710-2024-18966
    Event Type
    Malfunction
    Date Received
    April 4, 2024
    Date of Event
    March 11, 2024
    Report Date
    April 4, 2024
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    UDI-DI
    10846446063486
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 81 OTHER - THE CUSTOMER REPORTED THAT THEY WILL NOT RETURN THE DEFECTIVE UNIT/PART FOR EVALUATION. THEREFORE, NO ROOT CAUSE COULD BE DETERMINED. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE. H3 OTHER TEXT : DEVICE WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS UNABLE TO VERIFY THE CUSTOMER COMPLAINT. THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. VYAIRE RECEIVED ASSEMBLY, BATTERY, MK3 PART NUMBER: 16387 LOT CODE: 030123-LD. VISUALLY INSPECTED ON UUT (UNIT UNDER TEST) ASSEMBLY, THERE WAS NO VISIBLE DEFECT, CONTAMINATION, OR ANY DAMAGED. THE UUT WAS INSTALLED INTO A KNOWN GOOD SIPAP TEST VENT. POWERED THE UUT WITHOUT AC CONNECTED AND THE SCREEN APPEARED IN DIAGNOSIS MODE. CYCLED ON/OFF MULTIPLE TIMES AND NO ALARM ERRORS APPEARED ON SCREEN. ALLOWED THE BATTERY TO CHARGE FOR A PERIOD OF 18 HOURS, MEASURED VOLTAGE OUTPUT. THE REPORTED COMPLAINT WAS NOT CONFIRMED OR DUPLICATED. THE UUT WAS BELOW VOLTAGES SPECIFICATIONS AND CAN BE DETERMINED BY THE SUPPLIER IF A TREND IS IDENTIFIED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL PROBLEM WITH THE SIPAP VENTILATOR IN WHICH THE END USERS ARE REPORTING THAT WHEN THEY POWERED ON THE DEVICE, THE SCREEN 'WENT BLANK.'. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    57701 INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC KIT,SIPAP,IF,PLUS,AUX,MDISS,ENGLISH 10846446063486

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown