BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 16390421 · Received February 16, 2023

    Report

    Report Number
    2021710-2023-17292
    Event Type
    Death
    Date Received
    February 16, 2023
    Date of Event
    January 20, 2023
    Report Date
    February 16, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    00845873002726
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    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 VYAIRE FAILURE ANALYSIS LABORATORY RECEIVED THE SUSPECT COMPONENT AND PERFORMED A FAILURE INVESTIGATION. VYAIRE MEDICAL WAS UNABLE TO CONFIRM THE ISSUE AS THERE WAS NO FAILURE TO REPORT. THE UUT WAS TESTED AND FOUND TO MEET SPECIFICATIONS. THE EVENT TRACE REVIEW DETERMINED THAT THE VENTILATOR PERFORMED AS EXPECTED AND WAS NOT OPERATIONAL ON THE REPORTED DATE OF THE PATIENT EVENT ON (B)(6) 2023. 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 TO VYAIRE MEDICAL THAT A PATIENT DIED BUT THAT THE PATIENT WAS NOT ON THE UNIT AT THE TIME OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385214 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTV 1150 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death