BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1150 VENTILATOR

    MDR report key: 17279412 · Received July 7, 2023

    Report

    Report Number
    2021710-2023-17912
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 7, 2023
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K101643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    H3: 81 OTHER - AT THIS TIME, THE SUSPECT DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. THEREFORE, ROOT CAUSE HAS NOT BEEN DETERMINED YET. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE H3 OTHER TEXT : DEVICE NOT RETURNED YET.

    Description of Event or Problem · 0

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE SPONTANEOUS BREATHING TRIAL ( SBT) MODE COMES ON INTERMITTENTLY DURING USE ON A PATIENT ON THE LAP TOP VENTILATOR 1150. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    421416 LTV 1150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown