BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL LTV 1100 VENTILATOR

    MDR report key: 9179923 · Received October 11, 2019

    Report

    Report Number
    2031702-2019-03335
    Event Type
    Malfunction
    Date Received
    October 11, 2019
    Date of Event
    September 11, 2019
    Report Date
    October 11, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K101643
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL COMPLAINT NUMBER: (B)(4). RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS NOT ABLE TO DUPLICATE THE CUSTOMER'S REPORTED ISSUE DURING TESTING AND EVALUATION. DURING BENCH TESTING, THE UNIT WOULD NOT POWER ON. VYAIRE MEDICAL INSTALLED GOOD KNOW TEST PIGTAIL AND ISSUE WAS RESOLVED. VYAIRE MEDICAL REPLACED THE PIGTAIL TO ADDRESS THE ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR SHUTS DOWN WHEN CONNECTED TO THE LTM. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THIS REPORTED EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    974398 MODEL LTV 1100 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTM II

    Patients

    Seq Age Sex Outcome Treatment
    1