BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

    MDR report key: 16061837 · Received December 28, 2022

    Report

    Report Number
    2021710-2022-17083
    Event Type
    Malfunction
    Date Received
    December 28, 2022
    Date of Event
    December 5, 2022
    Report Date
    December 28, 2022
    Manufacturer
    CBK
    Product Code
    CBK
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. DEVICE NOT RETURNED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT E32 ERROR (ZERO VALVE ACTIVATION FAULT (VIA SENSE)) OCCURRED ON THE SIPAP VENTILATOR. THE CUSTOMER REPORTED THE EVENT WAS DETECTED DURING SET-UP PRIOR TO PATIENT USE ON WHICH THE DEVICE ALREADY PASSED TESTING. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1923457 INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION VENTILATOR, CONTINUOUS, FACILITY USE CBK CBK INFANT FLOW SIPAP

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown