BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 7063354 · Received November 28, 2017

    Report

    Report Number
    2021710-2017-07030
    Event Type
    Malfunction
    Date Received
    November 28, 2017
    Date of Event
    November 6, 2017
    Report Date
    February 7, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER WILL BE INCLUDED IN A FOLLOW-UP REPORT. THE SERVICE CENTER RECEIVED THE USER INTERFACE MODULE (UIM) FOR THE REPAIR AND EVALUATION. THE SUSPECT UIM COMPONENT WAS BENCH TESTED, INSPECTED CONNECTIONS AND COMPONENTS WITHIN THE UIM BY THE SERVICE GROUP, WHICH DUPLICATED THE CUSTOMER EVENT. THE EVALUATION DETERMINED THE UIM DISPLAY ASSEMBLY WAS THE CAUSE OF THE REPORTED EVENT. THE UIM DISPLAY ASSEMBLY WAS ROUTED TO THE FAILURE ANALYSIS (FA) LABORATORY FOR A COMPONENT ROOT CAUSE INVESTIGATION. ONCE THE FA LABORATORY INVESTIGATION IS COMPLETE A FOLLOW REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    THE VYAIRE FAILURE ANALYSIS (FA) LABORATORY RECEIVED THE SUSPECT DISPLAY COMPONENT FOR INVESTIGATION. THE FA PERFORMED A VISUAL INSPECTION OF THE INTERNAL COMPONENTS OF THE DISPLAY, WHICH FOUND A SCRATCH ON THE TOUCHSCREEN OF THE DISPLAY. THEY ALSO PERFORMED MULTIPLE POWER ON CYCLES ON THE SUSPECT DISPLAY AND EACH TIME THE TOUCHSCREEN WOULD NOT RESPOND. AT THIS TIME, THE FA WAS ABLE TO DUPLICATE THE REPORTED ISSUE. THE ROOT CAUSE COMPONENT FAILURE IS ASSOCIATED WITH COMPONENT DAMAGE TO THE TOUCHSCREEN THE ETIOLOGY HOWEVER, IS UNDETERMINED. THIS ISSUE WILL BE INTERNALLY INVESTIGATED WITHIN VYAIRE MEDICAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THE USER INTERFACE MODULE (UIM) DISPLAY SCREEN ON THIS VENTILATOR DEVICE IS UNRESPONSIVE TO TOUCH COMMANDS. THE CUSTOMER STATED THAT THIS UNIT WAS NOT ON A PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843540 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC AVEA

    Patients

    Seq Age Sex Outcome Treatment
    1