BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 10820275 · Received November 10, 2020

    Report

    Report Number
    2021710-2020-12845
    Event Type
    Death
    Date Received
    November 10, 2020
    Date of Event
    October 15, 2020
    Report Date
    October 15, 2020
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    00845873002726
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE EQUIPMENT WAS RECEIVED IN VYAIRE FACILITY FOR EVALUATION AND THE UNIT IS PLACED ON EXTENDED TESTS/RUN-IN. NO ROOT CAUSE HAS BEEN DETERMINED AT THIS TIME, SINCE THE INVESTIGATION IS STILL ONGOING. 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 · 1

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT A PATIENT DIED WHILE USING LAP TOP VENTILATOR 1150. THE CUSTOMER IS REQUESTING FOR A DOWNLOAD OF EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281751 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTV 1150 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1 Death