BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 14280816 · Received May 4, 2022

    Report

    Report Number
    3004553423-2022-01512
    Event Type
    Malfunction
    Date Received
    May 4, 2022
    Date of Event
    April 5, 2022
    Report Date
    April 5, 2022
    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
    003

    Narratives

    Additional Manufacturer Narrative · 0

    VYAIRE FILE IDENTIFICATION: (B)(4). AT THIS TIME,THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR INVESTIGATION.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

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. LOGS SHOWS THAT THE END USER CONFIRMED THE "SHUT DOWN DIALOGUE BOX" AT 04/04/2022 15:45:49 AND CFB LOGS ACTIVATED FROM 04/04/2022 15:46:04 TILL 04/04/2022 17:12:40 (DEVICE TIME). FOR SOME UNKNOWN REASON, THE COMMUNICATION BETWEEN EPC AND CFB GOT INTERRUPTED HOWEVER ITS VISIBLE AS PER THE LOG ENTRY "VENT STATE-" 0 (THIS IS NORMAL, AS NO VENTILATION WAS RUNNING AT THAT TIME). USER FORCE SHUTDOWN THE UNIT AT 04/04/2022 17:12:40. NURSE CALL IS ACTIVE, RED ALARM LIGHTS WERE ON AND THE BUZZER IS ACTIVE. THE UNIT START TO WORK NORMALLY AFTER THE NEXT RESTART AT 04/04/2022 17:14:09. THE CFB WAS NOT AFFECTED WHEN VENTILATION CONTINUED WITH THE LAST SETTINGS. THE EXACT ROOT CAUSE WAS NOT ESTABLISHED. MOST LIKELY THE ISSUE IS CAUSED BY A HARDWARE ISSUE ON THE EPC.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED BELLAVISTA1000 US BLANK SCREEN W/ LED AND AUDIBLE ALARM. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    379655 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown