BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BELLAVISTA

    MDR report key: 12540943 · Received September 28, 2021

    Report

    Report Number
    3004553423-2021-01201
    Event Type
    Injury
    Date Received
    September 28, 2021
    Date of Event
    August 31, 2021
    Report Date
    August 31, 2021
    Manufacturer
    IMTMEDICAL AG
    Product Code
    CBK
    UDI-DI
    07640149380019
    PMA / PMN Number
    K163127
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. HOWEVER, UNIT SCREENSHOT SHOWS PRESS PAT PROX AND PRESS MUSHROOM OUT OF TOLERANCE. LOGFILES SHOWS SOFTWARE MODEL ID 24661, 141106 / WARNING / ASSERTION FAILED PRESSURE CALIBRATION. VYAIRE MEDICAL IS SUSPECTING MULTIPLE SENSOR FAILURE ON LIFE BLOCK. RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS NOT RETURNED FOR INVESTIGATION. VYAIRE MEDICAL DETERMINED ROOT CAUSE AS DUE TO A DEFECTIVE PRESSURE SENSOR / TRANSDUCER OR CORRESPONDING MEASUREMENT ELECTRONICS ON THE LIFE BOARD ELECTRONICS ON THE LIFE BLOCK. ADC VALUES OF THE PRESSURE SENSOR "PRESS MUSHROOM" ON THE LIFE BOARD ELECTRONICS OF THE LIFE BLOCK ARE OUT OF THE SPECIFIED RANGE, TOO.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED BELLAVISTA1000 HAVING PEEP TOO HIGH ALARM AND THE FIRST STEP OF CALIBRATION DIDN'T. FURTHERMORE, THERE WAS NO INFORMATION FOR PATIENT HARM ASSOCIATED WITH THE EVENT. THE CUSTOMER CONFIRMED THAT HE RECEIVED THIS COMPLAINT WHEN THE DEVICE WAS CONNECTED TO THE PATIENT AND DISCONNECTION WAS GIVEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440066 BELLAVISTA VENTILATOR, CONTINUOUS, FACILITY USE CBK IMTMEDICAL AG BELLAVISTA1000 07640149380019

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention