BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 17144784 · Received June 16, 2023

    Report

    Report Number
    3004553423-2023-01906
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 19, 2023
    Report Date
    June 16, 2023
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    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

    DEVICE EVALUATION UPDATE:G3,G6,H2,H3,H6 AND H10 RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS ABLE TO CONFIRM THE ISSUE, AND THE UNIT UNDER TEST (UUT) WAS PHYSICALLY INSPECTED, WITH NO SIGNS OF DAMAGE OR MISUSE FOUND. THE UUT WAS PUT IN A KNOWN GOOD TOP LEVEL SYSTEM RUNNING SOFTWARE VERSION 6.1.0.2, AND AT STARTUP, THE BLOWER WAS HEARD ATTEMPTING TO CYCLE UP TO BLOW MANY TIMES BUT FAILING EACH TIME WITH A WHINE, AND HOME SCREEN ALARMS TF 401 AND 316 WERE TRIGGERED. THE BLOWER ASSEMBLY WAS DISASSEMBLED, BUT NO INDICATORS OF DAMAGE OR ANOMALIES WERE DISCOVERED ON THE RADIAL BLOWER. ROOT CAUSE OF FAILURE WAS DETERMINED DUE TO INTERNAL FAILURE OF THE RADIAL BLOWER OF THE BLOWER ASSEMBLY MOOG BELLAVISTA 1000 MANUFACTURED BY MOOG INC. MOST LIKELY THE FAILURE IS DUE TO THE BLOWER ELECTRONICS. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    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. H3 OTHER TEXT : DEVICE WAS NOT RETURNED YET.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE BELLAVISTA1000 US HAS A TECHNICAL FAILURE 401 - "INSPIRATION VALVE OR DEVICE LEAKY" AND BV - ALARM 316 - "BLOWER FAILURE". FURTHERMORE, THERE WAS NO PATIENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1013626 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown