BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 17538073 · Received August 13, 2023

    Report

    Report Number
    3004553423-2023-01953
    Event Type
    Malfunction
    Date Received
    August 13, 2023
    Date of Event
    July 6, 2023
    Report Date
    August 13, 2023
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO VERIFY THE REPORTED COMPLAINT. THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. VYAIRE RECEIVED INSPIRATION BLOCK ASSEMBLY BELLAVISTA 1000 P/N 030.200.050 S/N (B)(6) WITH ONBOARD PCBA P/N 301.214.000 REV07 S/N (B)(6) UNDER RGA 00032225. VISUAL INSPECTION OF THE UNIT UNDER TEST (UUT) FOUND THE INSPIRATION CONNECTOR NOT FULLY TIGHTENED ON THE INSPIRATION BLOCK; THERE WERE NO OTHER INDICATIONS OF DAMAGE OR MISUSE. THE UUT WAS INSTALLED, AS RECEIVED, INTO A KNOWN GOOD TOP-LEVEL SYSTEM RUNNING SOFTWARE VERSION 6.1.0.2, AND UPON STARTUP THE DISPLAY SHOWED THE STANDARD STARTUP SEQUENCE AS EXPECTED PERFORMING THE SELF-TEST AS USUAL AND THERE WAS ALARM TF 401 TRIGGERED. THE CIRCUIT ¿E¿ TEST WAS PERFORMED AND FAILED. THE BELLAVISTA UNIT WAS SHUTDOWN AND THE INSPIRATION CONNECTOR WAS TIGHTENED. AFTER CLEARING THE TF 401 AND A 30 MINUTE WARMUP, ZERO PRESSURE CALIBRATION WAS PERFORMED AND PASSED. CIRCUIT ¿E¿ TEST, TEST BASE UNIT, INSPIRATION VALVE OFFSET CALIBRATION, AND SELF TEST WERE PERFORMED AND PASSED. VENTILATION WAS CYCLED FOR 1 HOUR AND THERE WERE NO FURTHER ISSUES, ALARMS, OR WARNING MESSAGES. THE REPORTED COMPLAINT WAS DUPLICATED DUE TO A FAILURE CAUSED BY LOOSE INSPIRATION CONNECTOR.

    Additional Manufacturer Narrative · 0

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). H10: A VYAIRE FSR (FIELD SERVICE REPRESENTATIVE) EVALUATED THE DEVICE ONSITE. FSR ARRIVED ONSITE AND REPLACED INSPIRATION BLOCK, PERFORMED CALIBRATIONS, AND PERFORMED VERIFICATION WHICH ALL PASSED. REPAIR WAS COMPLETE. UNIT MEETS FACTORY SPECIFICATIONS. THE DEVICE READY FOR PATIENT USE. 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

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL PROBLEM WITH BELLAVISTA 1000 US GETTING TECHNICAL FAILURE 401 - INSPIRATION VALVE OR DEVICE LEAKY ALARM. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1073418 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown