BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 7087786 · Received December 6, 2017

    Report

    Report Number
    2031702-2017-02019
    Event Type
    Death
    Date Received
    December 6, 2017
    Date of Event
    November 1, 2017
    Report Date
    January 25, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS CURRENTLY IN HOUSE AND IS IN THE PROCESS OF BEING EVALUATED. ONCE COMPLETE, A FOLLOW-UP MEDWATCH FORM WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL TESTED THE VENTILATOR WITH A KNOWN GOOD AC ADAPTER AND A KNOWN GOOD PATIENT CIRCUIT CONNECTED. THE VENTILATOR PASSED 164 HOURS OF EXTENDED TESTS AT THE CUSTOMER¿S SETTINGS. THE VENTILATOR PASSED A 40 MINUTE BATTERY DURATION TEST. THE VENTILATOR ALSO PASSED THE LTV FINAL TEST WHICH INCLUDES MANY ALARM AND VENTILATION FUNCTIONS. EVENT TRACE LOG RESULTS: AN EVENT TRACE LOG WAS PULLED FROM THE VENTILATOR, THE DATE OF 1ST RECORD IN THE EVENT TRACE LOG WAS (B)(6) 2017, AND THE DATE OF THE LAST RECORD IN THE EVENT TRACE LOG WAS (B)(6)2017. THE TOTAL NUMBER OF RECORDS IN THE EVENT TRACE LOG WAS 455 OBSERVATIONS. A REVIEW OF EVENT TRACE LOG REVEALED SEVERAL ¿LN VENT1¿ CONDITIONS. THE EVENT TRACE LOG REVIEW REVEALED ¿LN VENT1¿ CONDITIONS WERE PRECEDED BY ¿BAT MPT1¿ CONDITIONS. ALL OTHER EVENT TRACE ENTRIES WERE CONSISTENT WITH NORMAL VENTILATOR OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT PASSED AWAY WHILE ON AN LTV VENTILATOR. THERE WERE NO ALLEGATIONS OF A VENTILATOR MALFUNCTION, HOWEVER, THE CUSTOMER WOULD LIKE THE UNIT TO BE EVALUATED AS A PRECAUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868802 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Death