BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVO 45 LS

    MDR report key: 19976204 · Received August 13, 2024

    Report

    Report Number
    9617566-2024-00003
    Event Type
    Death
    Date Received
    August 13, 2024
    Date of Event
    July 15, 2024
    Report Date
    August 13, 2024
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    07321822300004
    PMA / PMN Number
    K193586
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BREAS MEDICAL INC. DOES NOT HAVE ACCESS TO THE PHYSICAL DEVICE AT THIS TIME; HOWEVER, LOG FILES FROM THE DEVICE WERE OBTAINED WHICH WERE ANALYZED BY BREAS R&D. LOG FILES INDICATE THAT THE DEVICE, SN (B)(6), WAS NOT IN USE AT THE TIME THE EVENT WAS REPORTED TO HAVE OCCURRED ON JULY 15, 2024. THE LOG FILES SHOW DATA FROM (B)(6) 2024. TREATMENT DATA ENDS ON (B)(6) 2024. DATA FROM THE (B)(6) WAS RELATED TO DEVICE STATUS ONLY WITH THERE NO TREATMENT OCCURRING ON THOSE DAYS. THE LAST DATA IN THE LOG FILES IS ON (B)(6) AT THE TIME THE DOWNLOAD WAS DONE BY A BREAS EMPLOYEE. AFTER ANALYZING THIS DATA, THERE IS NO INDICATION OF CORRUPTION TO THE FILE. TREATMENT SESSIONS ARE RECORDED AS WELL AS ALARMS, ALL OF WHICH ARE CONSISTENT WITH DEVICE SPECIFICATIONS.

    Description of Event or Problem · 0

    ON 07/16/2024, BREAS RECEIVED THE FOLLOWING INFORMATION FROM DISTRIBUTOR (B)(4). "PT PASSED ON (B)(6) 2024 POSSIBLY IN LATE AFTERNOON. (B)(4) WASN'T INFORMED UNTIL 7/16 AND RECEIVED MINIMAL DETAILS. THE INCIDENT MAY HAVE HAPPENED WHILE THE PATIENT WAS IN TRANSPORT FROM A PPEC FACILITY THAT WATCHES CHILDREN. A COUSIN OF THE FAMILY WORKS ON A REFERRAL BASIS FOR A PERSONAL INJURY LAW FIRM AND MENTIONED THE SITUATION THE LAW FIRM. THE FAMILY ASKED FOR THE DATA, AND WHEN THEY WERE TOLD THAT (B)(4) WOULD NEED TO DOWN-LOAD THE DATA AND THEN GIVE THEM A COPY, THE ATTORNEYS TOOK POSSESSION OF THE DEVICE. (B)(4) INFORMED THE LAWYERS THAT THE DEVICE IS NOT THEIRS TO TAKE. THE LAWYERS ASKED FOR A PURCHASE OR RENTAL PRICE FOR THE DEVICE SO THAT THEY COULD RETAIN CUSTODY OF THE DEVICE. (B)(4) SUPPLIED THEM WITH A NUMBER THE LAWYERS THEN SAID THAT THEY WILL LOOK FOR "SOMEONE WHO CAN DOWNLOAD THE DATA". (B)(4) INFORMED THEM THAT WAS NOT A GOOD IDEA. THEY INFORMED THEM THAT AN UNQUALIFIED PERSON COULD POTENTIALLY DELETE ALL THE DATA WITH A PUSH OF THE WRONG BUTTON.". IT IS ALLEGED THAT THE PATIENT WAS CONNECTED TO A VIVO 45LS DEVICE, PART NUMBER: 230216 AND SERIAL NUMBER: (B)(6), AT THE TIME OF THE ADVERSE EVENT, BUT THIS IS NOT SUPPORTED BY THE LOG FILES OBTAINED FROM THE DEVICE (SEE ADDITIONAL COMMENTS). THERE HAS BEEN NO INDICATION THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE EVENT AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1619287 VIVO 45 LS VENTILATOR NOU BREAS MEDICAL AB VIVO 45 LS 07321822300004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death