BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION

    MDR report key: 6948870 · Received October 13, 2017

    Report

    Report Number
    2021710-2017-06785
    Event Type
    Malfunction
    Date Received
    October 13, 2017
    Date of Event
    September 15, 2017
    Report Date
    October 13, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    BZD
    PMA / PMN Number
    K031745
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). AT THIS TIME, VYAIRE MEDICAL HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FROM THE CUSTOMER FOR EVALUATION. IN THE EVENT THAT THE DEVICE IS RECEIVED FOR EVALUATION OR ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DISPLAY SCREEN WAS BLANK WHEN THE UNIT WAS TURNED ON. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727033 INFANT FLOW PLUS INFANT CPAP SYSTEM WITH SIPAP FUNCTION VENTILATOR, NON-CONTINUOUS BZD VYAIRE MEDICAL, INC SIPAP

    Patients

    Seq Age Sex Outcome Treatment
    1