BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BELLAVISTA

    MDR report key: 11856713 · Received May 20, 2021

    Report

    Report Number
    3004553423-2021-01028
    Event Type
    Malfunction
    Date Received
    May 20, 2021
    Date of Event
    April 27, 2021
    Report Date
    April 27, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149388183
    PMA / PMN Number
    K163127
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. NO EXACT ROOT CAUSE HAS BEEN ESTABLISH BUT MOST LIKELY IT IS DUE TO LACK OF SOFT-START ALGORITHM IN SOFTWARE V6.0.1400.0 CAUSED DAMAGE ON THE BLOWER DRIVING HARDWARE OF THE MAINBOARD DUE TO A TOO HIGH RESULTING CURRENT NEEDED TO OVERCOME ACTUAL INERTIA TORQUE OF THE BLOWER ROTOR. THIS COMPLAINT WILL BE INCLUDED WITH ON-GOING TRENDING ANALYSIS.

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL FILE IDENTIFICATION: (B)(4). A VYAIRE FIELD SERVICE REPRESENTATIVE(FSR) EVALUATED THE DEVICE ONSITE AND REQUESTED FOR FURTHER INFORMATION REGARDING TECHNICAL ERROR CODES. HE INITIATED WORK ORDER FOR THE BELLAVISTA UNIT AT NORTHWELL HEALTH STATEN ISLAND UNIVERSITY HOSPITAL, STATEN ISLAND, NY AS THE SAID UNIT HAS LEAKY INSPIRATORY BLOCK THAT NEEDS TO BE REPLACED. 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 TO VYAIRE MEDICAL THAT THE BELLAVISTA 1000 ALARMED 401 - INSPIRATION VALVE OR DEVICE LEAKY. FURTHERMORE, THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752185 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA 1000 US 07640149388183

    Patients

    Seq Age Sex Outcome Treatment
    1