BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAS VIVO 60

    MDR report key: 5077025 · Received September 15, 2015

    Report

    Report Number
    9617566-2015-00135
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Date of Event
    January 1, 2014
    Report Date
    September 14, 2015
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    PMA / PMN Number
    K123144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER EUROPEAN LAW, PATIENT INFORMATION IS CONSIDERED CONFIDENTIAL AND WILL NOT BE RELEASED BY THE HOSPITAL. THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR MODEL. VIVO 60 DOES NOT HAVE A PRODUCT CODE LISTED SO THE VIVO 50 PRODUCT CODE NOU IS USED. THE VIVO 50 510(K) NUMBER IS K123144. THIS MEDWATCH REPORT IS A RESULT OF A RETROSPECTIVE INVESTIGATION OF CUSTOMER COMPLAINTS AND HAS BEEN DEEMED REPORTABLE DUE TO INSUFFICIENT PATIENT INFORMATION. BASED UPON THE INFORMATION THAT BREAS PRESENTLY POSSESSES, IT IS UNABLE TO CONFIRM WHETHER THE EVENT IS REPORTABLE UNDER THE STANDARD SET FORTH IN THE APPLICABLE FDA REGULATIONS AND GUIDANCE. ACCORDINGLY, IN AN ABUNDANCE OF CAUTION, BREAS IS FILING A MEDWATCH REPORT FOR THIS EVENT. BEING PART OF A RETROSPECTIVE ANALYSIS, THIS REPORT IS SUBMITTED LATER THAN 30 DAYS AFTER THE INITIAL DATE ON WHICH BREAS BECAME AWARE OF THE EVENT, AS HAS PREVIOUSLY BEEN DISCUSSED WITH THE FDA.

    Description of Event or Problem · 1

    BREAS (B)(4) REPORTED A VIVO 60 DEVICE WITH A BATTERY ISSUE. THE INTERNAL BATTERY ICON HAD A RED CROSS LIKE IF IT'S OUT OF ORDER. WHEN WE HAVE RECONNECTED THE MAINS POWER, THE INTERNAL BATTERY ICON CAME BACK IN GREEN AND THE CHARGE WAS RUNNING. THE VIVO 60 IS NOT MARKETED IN THE USA, BUT THIS REPORT IS BEING SUBMITTED TO THE FDA SINCE THE VIVO 50 IN THE US IS A SIMILAR MODEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    608986 BREAS VIVO 60 VIVO 60 CONTINUOUS VENTILATOR NOU BREAS MEDICAL AB VIVO 60

    Patients

    Seq Age Sex Outcome Treatment
    1 Other