BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 12585719 · Received October 6, 2021

    Report

    Report Number
    3004553423-2021-01212
    Event Type
    Malfunction
    Date Received
    October 6, 2021
    Date of Event
    September 8, 2021
    Report Date
    September 8, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. VYAIRE MEDICAL DETERMINED ROOT CAUSE AS DUE TO A DEFECTIVE INSPIRATION VALVE NT. INITIATED INSPIRATION BLOCK REPLACEMENT. RAN UNIT BASE TEST, COMPLETE CALIBRATION AND PASSED. UNIT WORK ACCORDING TO SPECS.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. HOWEVER, VYAIRE MEDICAL WAS UNABLE TO ESTABLISH THE EXACT ROOT CAUSE AS THE ISSUE IS NO LONGER REPRODUCIBLE. VYAIRE FAILURE ANALYSIS RESULT SHOWS THAT THE VISUAL INSPECTION OF INSPIRATION BLOCK ASSEMBLY P# 030.200.050 WITH FLOW VALVE SN (B)(5) INSTALLED DID NOT SHOW SIGNS OF PHYSICAL DAMAGED. AFTER INSTALLING THE ASSEMBLY ONTO A KNOWN GOOD TOP-LEVEL SYSTEM, POWERED ON AND NO ALARM OCCUR. AFTER MULTIPLE SUCCESSFUL CIRCUIT CALIBRATIONS, THE SYSTEM WAS CYCLED FOR A MINIMUM OF 20 MINUTES, THE POWER CYCLED MULTIPLE TIMES, BUT NO ALARMS TRIGGERED. PERFORMED UNIT SELF-TEST AND INSPIRATION VALVE TEST BUT THE ISSUE WAS NOT REPRODUCED. ALL TEST PASSED ACCORDING TO MANUFACTURER SPECS.

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION AT THIS TIME. 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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BELLAVISTA1000E US GIVING ALARM 401 - INSPIRATION VALVE OR DEVICE LEAKY. FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1482716 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA1000E US 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown