BEUDAMED
    FDA Adverse Event Death Summary report: N

    VIVO 45LS

    MDR report key: 23294715 · Received October 15, 2025

    Report

    Report Number
    9617566-2025-00021
    Event Type
    Death
    Date Received
    October 15, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BREAS MEDICAL AB
    Product Code
    NOU
    UDI-DI
    07321822300004
    PMA / PMN Number
    K193586
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BREAS RECEIVED THE DEVICE ON SEPTEMBER 24, 2025, AND WAS INSPECTED BY THE BREAS SERVICE DEPARTMENT. THE INITIAL REPORT DID NOT ALLEGE THAT THE BREAS DEVICE CAUSE OR CONTRIBUTED TO THE PATIENT DEATH. THE INVESTIGATION CONCLUDED THAT THE BREAS DEVICE PERFORMED ACCORDING TO SPECIFICATION AND THERE WAS NO PROBLEM DETECTED WITH THE DEVICE. THIS REPORT WILL BE CLOSED.

    Description of Event or Problem · 0

    ON (B)(6) 2025, AT 6:52 PM ET, PATIENT SUPPORT REP (B)(6) CONTACTED DELIVERY TECHNICIAN (B)(6) ABOUT AN ISSUE WITH PATIENT (B)(6)' (11-YEAR-OLD PATIENT) PULSE OXIMETER. AT 6:58 PM ET, (B)(6) TROUBLESHOT THE DEVICE WITH MOM (B)(6) AND A (B)(6) IN-HOME NURSE. MOM HAD ALREADY CALLED 911 BEFORE CONTACTING AMS. EMERGENCY SERVICES TESTED PATIENTS' VITALS WITH THEIR EQUIPMENT AND CONCLUDED THE PATIENT WAS STABLE AND READINGS FROM (B)(6) EQUIPMENT PROVIDED SIMILAR RESULTS AND HAD LEFT. THE PATIENT WAS REPORTED STABLE AT THIS TIME. (B)(6) PREPARED REPLACEMENT EQUIPMENT AND DEPARTED FOR THE PATIENT'S HOME AT 7:20 PM ET. HE ARRIVED AT 9:20 PM ET, WHERE THE NURSE INFORMED HIM THAT 911 HAD BEEN CALLED AGAIN DURING HIS TRAVEL TIME. (B)(6) EXCHANGED BOTH THE PULSE OXIMETER AND PATIENT CABLE, WITH THE NURSE SIGNING FOR THE EXCHANGE. DURING THIS PROCESS, MOM CALLED THE NURSE AND INFORMED THEM THAT THE PATIENT HAD PASSED AWAY. AT 9:51 PM ET, (B)(6) CONTACTED HIS SUPERVISOR (B)(6), WHO INSTRUCTED HIM TO DOCUMENT THE INCIDENT. (B)(6) SENT DETAILED INFORMATION TO (B)(6). HE ADDED A NOTE TO THE PATIENT'S (B)(4) ACCOUNT, AND THE EQUIPMENT WAS QUARANTINED IN THE WAREHOUSE FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2288088 VIVO 45LS VENTILATOR NOU BREAS MEDICAL AB 230000 07321822300004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown PULSE OXIMETER