BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV 1000 VENTILATOR

    MDR report key: 7151440 · Received December 28, 2017

    Report

    Report Number
    2031702-2017-02041
    Event Type
    Injury
    Date Received
    December 28, 2017
    Date of Event
    November 30, 2017
    Report Date
    March 8, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. THE SUSPECT DEVICE WAS TAKEN OUT OF SERVICE AND EVALUATED BY THE FACILITIES BIO MEDICAL DEPARTMENT. THE CUSTOMER STATED THAT THE DEVICE FLICKERED ON STARTUP AND SHUT DOWN. ANOTHER ATTEMPT WAS MADE TO POWER THE DEVICE ON WHICH ALLOWED THE DEVICE TO POWER UP AND DOWNLOAD THE EVENT TRACE. AT THIS TIME, VYAIRE HAS NOT RECEIVED THE SUSPECT DEVICE/COMPONENT FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: A VYAIRE THIRD PARTY SERVICE TECHNICIAN WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. BENCH TESTING REVEALED A MALFUNCTIONING POWER BOARD. THE SERVICE TECHNICIAN REPLACED THE POWER BOARD AND THE REPORTED ISSUE WAS RESOLVED. THE DEVICE PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE MODEL LAP TOP VENTILATOR 100 SHUT DOWN WHILE CONNECTED TO A PATIENT. THE CUSTOMER CONFIRMED THERE WAS NO PATIENT HARM ASSOCIATED WITH THE REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    931524 LTV 1000 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention