BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6999691 · Received November 3, 2017

    Report

    Report Number
    2031702-2017-01981
    Event Type
    Death
    Date Received
    November 3, 2017
    Date of Event
    September 14, 2017
    Report Date
    December 28, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY IN HOUSE AT VYAIRE MEDICAL AND IS IN THE PROCESS OF BEING EVALUATED. ONCE COMPLETES AND THE RESULTS BECOME AVAILABLE, A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL PERFORMED MULTIPLE TESTS ON THE VENTILATOR. ALL TESTING WAS PERFORMED USING A GOOD KNOWN TEST AC ADAPTER AS WELL AS A GOOD KNOWN TEST PATIENT CIRCUIT. THE VENTILATOR PASSED AN EXTENDED 97 HOUR RUN IN TEST AT THE CUSTOMER'S SETTINGS WITHOUT ANY UNUSUAL ALARMS AND CONDITIONS. THE VENTILATOR ALSO PASSED THE LTV AUTOMATED FINAL TEST, WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS. THE EVENT TRACE LOG CONTAINS NO UNUSUAL ALARM TYPES OR INCIDENT COUNTS. ALL EVENT TRACE ENTRIES WERE CONSISTENT WITH NORMAL VENTILATOR OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE PATIENT PASSED AWAY WHILE CONNECTED TO THE VENTILATOR. THERE ARE NO ALLEGATIONS OF THE VENTILATOR MALFUNCTIONING, THE CUSTOMER WOULD LIKE TO GET THE VENTILATOR EVALUATED AS A PRECAUTION. THE PATIENT HAS TWO VENTILATORS, AND IT IS UNKNOWN AT THIS TIME WHICH VENTILATOR THE PATIENT WAS ON AT THE TIME OF THE EVENT. BOTH VENTILATORS WILL BE EVALUATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778399 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death