BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BREAS VIVO 60

    MDR report key: 6562630 · Received May 12, 2017

    Report

    Report Number
    9617566-2017-00004
    Event Type
    Malfunction
    Date Received
    May 12, 2017
    Date of Event
    February 25, 2017
    Report Date
    May 11, 2017
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    00732182215005
    PMA / PMN Number
    K123144
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UNDER (B)(6) 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 # (B)(4) HAVE BEEN USED IN THIS REPORT.

    Description of Event or Problem · 1

    THE PATIENT WAS VENTILATED AT (B)(6) THERAPEUTICS (B)(4) WITH A VIVO 60 FOR APPROXIMATELY 24 HOURS. ON (B)(6) 2017, THE DEVICE (SN (B)(4)) SHOWED AN ALARM OF "HUMIDITY COMPENSATION LOST". THE RESPONDING STAFF CHANGED THE DOUBLE LIMB CIRCUIT, WHICH SEEMED TO RESOLVE THE ISSUE. DURING THE NIGHT, THE SAME ALARM APPEARED AND THE BATTERY SYMBOL WAS OBSERVED BLINKING DESPITE THAT THE DEVICE WAS OPERATED ON MAINS ELECTRICITY. THE PATIENT WAS ADAPTED TO ANOTHER VIVO 60 (SN (B)(4)) AND THE VTE AND MV LOW ALARMS APPEARED SHORTLY THEREAFTER. THE PATIENT WAS RE-ADAPTED TO THE FIRST DEVICE (SN (B)(4)) WITH THE CHANGED CIRCUIT. THE A.M. PROBLEMS OCCURRED, FOLLOWED BY A BLACK-OUT. THE PATIENT WAS TRANSPORTED TO A NEARBY HOSPITAL. AFTER CONSULTING A MEDICAL TECHNICIAN AND A MEDICAL DIRECTOR, THE (B)(6) THERAPEUTICS DISCUSSED THIS SITUATION AND CONSULTED THE MANUFACTURER. THE DIFFERENT ALARMS ON BOTH THE DEVICES AND THE SUBSEQUENT BLACK-OUT COULD NEITHER BE EXPLAINED NOR DUPLICATED UNDER THE LABORATORY CONDITIONS. BECAUSE OF LACK OF AN EXPLANATION AND THE QUICK SUCCESSION OF DIFFERENT ALARMS ON THESE DEVICES, IT WAS RECOMMENDED THAT THE MANUFACTURER INVESTIGATE THESE INCIDENTS AND PERFORM ADDITIONAL TESTS. THE FIRST REPORT WAS CREATED BY THE (B)(6) CENTER AND THE RESULT OF THE TEST FROM (B)(6) CAN BE PROVIDED VIA E-MAIL UPON REQUEST. 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
    346169 BREAS VIVO 60 VIVO 60 CONTINOUS VENTILATOR NOU BREAS MEDICAL AB VIVO 60 00732182215005

    Patients

    Seq Age Sex Outcome Treatment
    1 Other