BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAS MEDICAL INC.

    MDR report key: 12622208 · Received October 13, 2021

    Report

    Report Number
    9617566-2021-00004
    Event Type
    Malfunction
    Date Received
    October 13, 2021
    Date of Event
    September 14, 2021
    Report Date
    October 13, 2021
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    CBK
    PMA / PMN Number
    K193586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED FOR ANALYSIS ON 10/05/2021. THE DEVICE WAS INSPECTED AND NO VISIBLE DAMAGE WAS OBSERVED. DEVICE LOG FILES WERE DOWNLOADED. THE ANALYSIS OF THE LOG FILES DEMONSTRATES THAT THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. DURING THE TIME OF THE EVENT, THE DEVICE LOGS SHOW THAT STOP OF TREATMENT WAS INITIATED MANUALLY BY A LONG PRESS OF THE START/STOP BUTTON AND CONFIRMED MANUALLY BY PRESSING THE 'OK' BUTTON. THIS IS THE INTENDED FUNCTIONALITY OF THE STOP OF TREATMENT (STANDBY MODE) FEATURE WHICH REQUIRES TWO SEPARATE BUTTON PRESSES TO ENTER STANDBY MODE. THE INVESTIGATION RESULTS SUPPORT THE CONCLUSION THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INCIDENT.

    Description of Event or Problem · 1

    BREAS MEDICAL INC. WAS NOTIFIED OF AN EVENT THAT OCCURRED ON (B)(6) 2021, INVOLVING A VIVO 45 LS. THE SITE REPORTED THAT THE DEVICE BEGAN ALARMING BEFORE IT WENT INTO STANDBY MODE AND STOPPED VENTILATING WHILE CONNECTED TO AN INFANT. THERE WAS AN ATTENDING RN PRESENT AT THE TIME OF THE EVENT WHO REPORTED THAT THE PATIENT DESATURATED TO 88% AND WAS TAKEN OFF THE VIVO 45 LS, PLACED ONTO ANOTHER HOSPITAL VENTILATOR AND STABILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526939 BREAS MEDICAL INC. VIVO45 LS CBK BREAS MEDICAL AB VIVO 45 LS US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention