BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAS VIVO 60

    MDR report key: 6753536 · Received July 31, 2017

    Report

    Report Number
    9617566-2017-00014
    Event Type
    Malfunction
    Date Received
    July 31, 2017
    Date of Event
    July 20, 2017
    Report Date
    July 31, 2017
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    00732182215005
    PMA / PMN Number
    K123144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    SERVICE PERSONNEL

    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 SIMILAR MODEL. THEREFORE, THE VIVO 50 PRODUCT CODE NOU, THE VIVO 50 510(K)#K123144, AND THE VIVO 50 UDI #732182215005 HAVE BEEN USED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS VENTILATED WITH A VIVO 60. ON (B)(6) 2017, THE DEVICE STOPPED WITHOUT WARNING AND ALARM WHILE THE USER WAS TRANSPORTED TO THE HOSPITAL. THE DEVICE WAS ABLE TO RESTART BUT AFTER A SHORT WHILE IT STOPPED AGAIN. BASED ON THE INFORMATION PROVIDED AT THIS TIME, INCLUDING INVESTIGATION RESULTS INDICATING A USE ERROR, THE REPORTED EVENT IS CONSIDERED REPORTABLE PER 21 CFR PART 803.3.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534008 BREAS VIVO 60 VIVO 60 CONTINOUS VENTILATOR NOU BREAS MEDICAL AB VIVO 60 00732182215005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other