BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 2150 VENTILATOR

    MDR report key: 12392514 · Received August 31, 2021

    Report

    Report Number
    2021710-2021-14455
    Event Type
    Malfunction
    Date Received
    August 31, 2021
    Date of Event
    August 3, 2021
    Report Date
    August 3, 2021
    Manufacturer
    VYAIRE MEDICAL INC.
    Product Code
    CBK
    PMA / PMN Number
    K101643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RESULT OF INVESTIGATION: VYAIRE MEDICAL WAS DUPLICATE AND ISOLATE THE REPORTED PROBLEM TO FAILED U7 REG BUCK SYNC ADJ 12A 16-PQFN P/N 24570-001. FURTHER INSPECTION FOUND LED D4 FROM POWER BOARD P/N 22620-001 S/N (B)(6) TO BE FLASHING. TROUBLE SHOOTING FOUND INTEGRATED CIRCUIT U7 REG BUCK SYNC ADJ 12A 16-PQFN P/N 24570-001 TO HAVE FAILED. IC U7 VOLTAGE INPUT MEASURE IS WITHIN SPEC AT 14.0VDC. IC U7 REGULATED VOLTAGE OUTPUT MEASURED 0.0VDC. VYAIRE MEDICAL WILL SUBMIT A SUPPLEMENTAL REPORT IN ACCORDANCE WITH 21 CFR SECTION 803.56 IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO VYAIRE MEDICAL THAT THE LAP TOP VENTILATOR 2150 SHUTDOWN WHILE ON A PATIENT. THE CUSTOMER CONFIRMED THAT THERE IS NO PATIENT HARM ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294414 LTV 2150 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL INC. LTV 2150

    Patients

    Seq Age Sex Outcome Treatment
    1