BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 15395059 · Received September 9, 2022

    Report

    Report Number
    3004553423-2022-01625
    Event Type
    Malfunction
    Date Received
    September 9, 2022
    Date of Event
    August 11, 2022
    Report Date
    August 11, 2022
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT COMPONENT WAS RETURN TO VYAIRE MEDICAL FOR EVALUATION. A VISUAL INSPECTION OF BELLAVISTA INSPIRATION BLOCK ASSEMBLY P# 030.200.050 WITH FLOW VALVE SN (B)(6) INSTALLED DID NOT SHOW SIGNS OF PHYSICAL DAMAGE TO IT. AFTER INSTALLING THE ASSEMBLY INTO A KNOWN GOOD TOP LEVEL SYSTEM THE SYSTEM WAS POWERED ON, DEVICE ISSUE WAS IMMEDIATELY REPRODUCED TF 401 ALARM. AFTER ENTERING INTO SERVICE MODE AND CONFIGURING THE BLOWER SPEED TO 30% AND OCCLUDING THE INSPIRATION PORT THE FLOW MEASURED <0.2L/MIN INDICATING A LEAKING INSPIRATION VALVE NT. VENT CYCLED 10X TIMES AFTER VERIFYING THE ELECTRICAL CONNECTIONS INSIDE THE VENT AND THE ALARM 316 WENT AWAY, BUT THE 401 ONLY CAME UP ONE TIME AFTER 10 RESTARTS. ADVISED CUSTOMER THAT THE VENT NEEDS NEW INSP BLOCK TO RESOLVE THE ISSUE. THE ROOT CAUSE WAS DETERMINED DUE TO LEAKING INSPIRATION VALVE NT.

    Additional Manufacturer Narrative · 0

    VYAIRE FILE IDENTIFICATION:(B)(4). THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. HOWEVER, VYAIRE FIELD SERVICE REPRESENTATIVE(FSR) EVALUATED THE DEVICE ONSITE AND VERIFIED THAT THE UNIT STARTS UP WITH ERROR 401. THEY ATTEMPTED CIRCUIT CHECK, REASSEMBLED, CYCLED POWER TEN TIMES AND THERE WAS NO ERROR ON ALL TEN. PERFORMED COMPLETE UNIT CALIBRATION AND PASSED. ADVISED THAT THE INSPIRATION BLOCK NEEDS TO BE REPLACED. INSTALLED NEW INSP BLOCK, REPLACED O2 SENSOR DAMAGED DURING REPAIR, PERFORMED TEST BASE PROCEDURE, PM/CALIBRATION PROCEDURE, AND VERIFICATION PROCEDURE, ALL TESTS AND CALIBRATIONS PASSED. VENTILATOR IS OPERATING WITHIN VYAIRE SPECIFICATIONS. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME, SINCE THE INVESTIGATION IS STILL ONGOING. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE BELLVISTA1000 US IS SHOWING ALARM 401 - INSPIRATION VALVE OR DEVICE LEAKY UPON UNIT START UP. FURTHERMORE, WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306705 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown