BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AVEA VENTILATOR

    MDR report key: 17931470 · Received October 13, 2023

    Report

    Report Number
    2021710-2023-18276
    Event Type
    Malfunction
    Date Received
    October 13, 2023
    Date of Event
    September 14, 2023
    Report Date
    October 13, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K103211
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H3: 81 OTHER - 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.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: H10 RESULTS OF INVESTIGATION: VYAIRE MEDICAL RECEIVED THE DEVICE FOR EVALUATION. A VISUAL INSPECTION WAS PERFORMED AND FOUND 3 MISSING SCREWS ON RIGHT SIDE OF REAR BEZEL. UIM WAS CONNECTED TO AVEA TEST STATION 93096-3 AND POWERED ON. NOTICED UIM POWER CYCLE ON WHITE SCREEN NUMEROUS TIMES BEFORE ENTERING USER MODE. UIM DISPLAYED 4.6B IS THE INSTALLED SOFTWARE. SYSTEM WAS LEFT TO CYCLE ON LAST KNOWN USER SETTINGS. VERIFIED TOUCH SCREEN AND MEMBRANE SWITCH PANEL FUNCTIONALITY, NO ISSUES WERE NOTED. POWER WAS CYCLED INTERMITTENTLY, OBSERVED LCD SCREEN HAD SYMPTOMS OF IMAGE RETENTION DURING WHITE SCREEN ON BOOT UP. MEMBRANE SWITCH SOFTKEYS WERE PRESSED REPEATEDLY SEVERAL TIMES IN ATTEMPT TO DUPLICATE FAILURE, NO ISSUES WERE DISPLAYED. SOFTKEY FEEDBACK FELT TO HAVE SOME WEAR. UIM WAS LEFT TO RUN OVERNIGHT. TOUCH SCREEN AND SOFTKEYS WERE AGAIN TESTED IN ATTEMPT TO DUPLICATE FAILURE AND NO ISSUES WERE OBSERVED. UIM WAS POWERED DOWN AND COVERS WERE REMOVED TO INSPECT INTERNAL COMPONENTS. UPON REMOVING REAR BEZEL FROM ASSEMBLY FOUND TOP CENTER, TOP RIGHT SCREW MOUNTS WERE FOUND TO BE BROKEN FROM OVERTIGHTENING OF SCREWS. CORROSION FROM MOISTURE WAS ALSO FOUND IN SEVERAL AREAS OF INNER FRONT BEZEL AND INTERNAL PLATE. LCD SCREEN SHOWS EVIDENCE OF INGRESS OF FLUID ON BOTTOM CORNERS OF GASKET. MEMBRANE RIBBON CABLE ENTRY POINT SHOWS EVIDENCE OF INGRESS OF FLUID ENTERING TO MEMBRANE SWITCH PANEL SIDE OF BEZEL. RIBBON CABLES WERE INSPECTED AND FOUND NO SIGNS OF DAMAGE. THE REPORTED COMPLAINT WAS NOT CONFIRMED. THE REPORTED COMPLAINT WAS UNABLE TO BE REPRODUCED DURING EVALUATION, HOWEVER UPON INSPECTING UIM INTERNALS CORROSION WAS FOUND IN SEVERAL AREAS FROM INGRESS OF FLUID WHICH IS LIKELY TO BE THE CAUSE OF THE REPORTED FAILURE. 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 SUPPLEMENTAL REPORT HAS CORRECTED THE REFERENCED DEVICE TO THE VENTILATOR. NOTE THAT THE UDI-DI HAS BEEN IDENTIFIED BUT THE UDI-PI IS NOT AVAILABLE AS THIS INFORMATION WAS NOT MADE AVAILABLE TO VYAIRE MEDICAL.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT ACCEPT BUTTON ACTIVATES THE MODE BUTTON ON THE AVEA VENTILATOR. THE CUSTOMER REPORTED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1716734 AVEA VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL 17312-00

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown