BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 14116100 · Received April 14, 2022

    Report

    Report Number
    2021710-2022-15885
    Event Type
    Death
    Date Received
    April 14, 2022
    Date of Event
    March 14, 2022
    Report Date
    March 17, 2022
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    UDI-DI
    00845873002726
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE SUSPECT DEVICE WAS RETURNED AND EVALUATION IS ANTICIPATED BUT NOT YET BEGUN. ONCE A FINAL INVESTIGATION IS COMPLETE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    RESULTS OF INVESTIGATION: THE SUSPECT DEVICE WAS RETURNED FOR INVESTIGATION. VYAIRE MEDICAL WAS NOT ABLE TO VERIFY THE CUSTOMER COMPLAINT REGARDING PATIENT EXPIRING ON THE VENT AND EVENT TRACE REVIEW WAS REQUESTED. THERE IS NO REPORTED FAILURE FOUND WITH THE DEVICE; THUS, NO ROOT CAUSE WAS ESTABLISHED. A VISUAL INSPECTION OF THE UNIT UNDER TEST (UUT) WAS PERFORMED. FOUND SUPERFICIAL DAMAGES WITH SCRATCHES TO THE BOTTOM CENTER OF THE FRONT WELDMENT; DEEP SCRATCHES TO THE CENTER PORTION OF THE BATTERY TRAY AND REAR WELDMENT; AND PHYSICAL DAMAGES TO WARNING AND SERIAL NUMBER LABELS. FURTHER INSPECTION REVEALED DUST-LIKE DEBRIS ON THE FAN FILTER AND AIR INLET FILTER. WITH AN EXTERNAL POWER CONNECTED, THE POST AND EVENT TRACE LOG WERE PRODUCED AND REVIEWED. THE UUT UNDERWENT A VENT CHECK AND PASSED ON ALL COUNTS INCLUDING ALARM, DISPLAY, CONTROL, AND LEAK TEST WITH NO ISSUES FOUND. A REVIEW OF UUT'S DHR PER ETA FACTORY VIEW V1.0 FOUND THAT UUT WAS LAST FINAL TEST ON 25-APRIL-2017 WHICH ALSO PASSED ON ALL COUNTS. DHR REVIEW PER MADE2MANAGE FOUND THAT UUT WAS LAST PM ON 05-FEB-2021 AT 14,510 HOURS FOR A 10K PM. ADDITIONALLY, UUT'S DATE OF MANUFACTURE IS 05-MAY-2017. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED PROBLEM WITH LAP TOP VENTILATOR 1150 WHERE THE NURSE WENT IN TO WAKE THE PATIENT UP FOR THE MORNING ROUNDS, BUT DISCOVERED THE PATIENT UNRESPONSIVE AND THE PATIENT LATER DIED. NO ALARM WAS NOTED AS THE STAFF WERE ENTERING THE ROOM FOR ROUTINE TASKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140454 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. LTV 1150 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death