BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVI 65

    MDR report key: 15189632 · Received August 9, 2022

    Report

    Report Number
    9617566-2022-00006
    Event Type
    Death
    Date Received
    August 9, 2022
    Date of Event
    April 10, 2022
    Report Date
    August 9, 2022
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    CBK
    UDI-DI
    07321822245169
    PMA / PMN Number
    K160481
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BREAS MEDICAL INC. WAS NOT NOTIFIED INITIALLY WHEN THE ADVERSE EVENT OCCURRED. THE INFORMATION WAS OBTAINED THROUGH HEARSAY AND IN THE INITIAL INVESTIGATION, BREAS MEDICAL INC. WAS UNABLE TO GAIN ANY INFORMATION ABOUT THE EVENT AND/ OR VERIFY THAT THE EVENT ACTUALLY HAPPENED. IN A LATER INVESTIGATION, BREAS MEDICAL INC. MADE CONTACT WITH THE DME IN POSSESSION OF THE VENTILATOR AND WAS ABLE TO GET DETAILS ABOUT THE EVENT AS INDICATED IN THIS REPORT. THE DEVICE HAS NOT BEEN RETURNED TO BREAS MEDICAL INC. AT THIS TIME, BUT WE DID RECEIVE THE LOG FILES FOR THE DEVICE FROM THE DME AND OUR ENGINEERING TEAM WAS ABLE TO ANALYZE THOSE FILES. THE CONCLUSION FROM THE ANALYSIS IS THAT THE DEVICE PERFORMED ACCORDING TO SPECIFICATION. ON THE DATE OF THE EVENT, THERE WERE ALARMS RELATED TO PRESSURE AND VOLUME LIMITS EXCEEDED. THERE WERE NO POWER FAILURES OR OTHER STOPS IN TREATMENT THROUGHOUT THE DAY ON (B)(6), WITH THE EXCEPTION OF ONE STANDBY EVENT AT 23:59:54 ON (B)(6) WHICH INDICATES THAT TREATMENT WAS MANUALLY STOPPED ON THE DEVICE. THE INVESTIGATION RESULT SUPPORTS THE CONCLUSION THAT THE DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE INCIDENT.

    Description of Event or Problem · 0

    BREAS MEDICAL INC. HAS DETERMINED THAT AN EVENT OCCURRED ON (B)(6) 2022 INVOLVING A VIVO 65 VENTILATOR. THIS EVENT WAS NOT REPORTED BY THE SITE. THE DME HAS ADVISED THAT A CHILD DIED WHILE CONNECTED TO A VIVO 65 DEVICE AND IN A CAR TRAVELLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1989103 VIVI 65 VENTILATOR CONTINOUS FACILITY USE CBK BREAS MEDICAL AB VIVO65 07321822245169

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death