BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6918209 · Received October 5, 2017

    Report

    Report Number
    2031702-2017-01954
    Event Type
    Death
    Date Received
    October 5, 2017
    Date of Event
    September 8, 2017
    Report Date
    October 5, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. RESULTS OF INVESTIGATION: A VYAIRE CERTIFIED SERVICE TECHNICIAN EVALUATED THE DEVICE. THE DEVICE PASSED 70 HOUR EXTENDED TESTS AT THE CUSTOMER'S SETTINGS. THE DEVICE PASSED THE LAP TOP VENTILATOR FINAL TEST, WHICH INCLUDES MANY ALARM AND DEVICE FUNCTIONS. THE EVENT TRACE CONTAINS NO UNUSUAL ALARM TYPES OR INCIDENT COUNTS. ALL EVENT TRACE ENTRIES ARE CONSISTENT WITH NORMAL DEVICE OPERATION. THE DEVICE PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT A PATIENT PASSED AWAY WHILE CONNECTED TO MODEL LAP TOP 1150 AND NON-INVASIVE TESTING WAS REQUESTED. THE HOME HEALTH NURSE WAS WITH THE PATIENT, LEFT THE ROOM FOR A FEW MINUTES, RETURNED TO THE ROOM AND THE PATIENT HAD PASSED AWAY. THE CUSTOMER STATED THAT IT IS NOT BELIEVED THAT THE DEVICE HAD ANYTHING TO DO WITH THE PATIENT¿S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698196 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Death