BEUDAMED
    FDA Adverse Event Summary report: N

    BREAS VIVO 50

    MDR report key: 6112205 · Received November 18, 2016

    Report

    Report Number
    9617566-2016-00004
    Date Received
    November 18, 2016
    Date of Event
    October 1, 2016
    Report Date
    November 18, 2016
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    07321822150005
    PMA / PMN Number
    K123144
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    HEALTHCARE FACILITY IN THE (B)(6) REPORTS A PROBLEM ENCOUNTERED WITH A BREAS VIVO 50 VENTILATOR DURING TREATMENT. PER THE INITIAL REPORTER: "THE VENTILATOR WAS DISCOVERED TO HAVE TURNED OFF FOR A PERIOD OF 38 MINUTES. STAFF HAD TO PHYSICALLY TURN THE MACHINE BACK ON. THE RESIDENT DID NOT COME TO HARM. VENTILATOR TAKEN OUT OF USE AND ENGINEER CONTACTED TO CHECK THE MACHINE. THIS WAS TAKEN AWAY BY DEVA MEDICAL AND CHECKED. THEY COMPLETED ALL CHECKS AND THEY COULD FIND NO FAULT WITH THE MACHINE. THE HISTORY DISPLAY SHOWS THAT TREATMENT WAS STOPPED AT 18.16 AND THEN RESTARTED AT 18.59. A FULL INVESTIGATION HAS TAKEN PLACE AND THE OUTCOME WAS THAT THE MACHINE HAS AN INTERMITTENT FAULT, AS IT HAD DONE THIS AT LEAST ONCE BEFORE. A DELIBERATE ACT OF TURNING OFF THE VENTILATOR HAS BEEN RULED OUT." THE REPORTER CLAIMS THERE WAS NO PATIENT INJURY AS A RESULT OF THE REPORTED EVENT, BUT IF THE SITUATION WERE TO RECUR, IT MIGHT POTENTIALLY RESULT IN SERIOUS INJURY. AT THIS POINT, THE INITIAL REPORTER ALSO CONCLUDED "INTERMITTENT FAULT COULD NOT BE RULED OUT, NEITHER COULD HUMAN INTERVENTION" AFTER THEIR CONTRACTED SERVICE PARTNER DEVA COULD NOT FIND ANYTHING WRONG WITH THE DEVICE - THE DEVICE PASSED ALL ITS TESTS. 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
    765606 BREAS VIVO 50 CONTINUOUS VENTILATOR NOU BREAS MEDICAL AB VIVO 50 07321822150005

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other