BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1000 VENTILATOR

    MDR report key: 6974711 · Received October 24, 2017

    Report

    Report Number
    2031702-2017-01968
    Event Type
    Malfunction
    Date Received
    October 24, 2017
    Date of Event
    September 26, 2017
    Report Date
    December 29, 2017
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS OF INVESTIGATION: THIS UNIT WAS FIELD SERVICED BY A VYAIRE MEDICAL AUTHORIZED SERVICE TECHNICIAN. THE SERVICE TECHNICIAN WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE DURING TESTING AND EVALUATION. THE SERVICE TECHNICIAN REPLACED THE POWER BOARD TO ADDRESS THE CUSTOMER'S REPORTED ISSUE.

    Additional Manufacturer Narrative · 1

    RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS UNABLE TO DUPLICATE THE CUSTOMER'S REPORTED ISSUE. DURING THE INITIAL BENCH TEST AND CALIBRATION TEST, THE POWER BOARD POWERED UP THE GOLDEN TESTING VENTILATOR, PASSED FULL CALIBRATION TEST, PASSED POWER CHECK OUT, PASSED BATTERY CHARGING TEST, PASSED ALL TEST SETTINGS, AND WAS WORKING NORMALLY IN SPECIFICATION. THE UNIT ALSO PASSED A 4 HOUR EXTENDED DURATION TEST AND DID NOT PRODUCE ANY UNUSUAL ALARM OR ERROR CONDITIONS. THE SERVICE TECHNICIAN WAS UNABLE TO DETERMINE WHAT THE PROBLEM WAS DUE TO THE UNIT NOT BEING RETURNED WITH THE POWER BOARD. VISUAL INSPECTION OF THE POWER BOARD DID NOT REVEAL ANY ANOMALIES AND FOUND NO SIGNS OF OVERHEATING OR DAMAGED COMPONENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE UNIT HAD A RESET ALARM OCCUR. THE SERVICE TECHNICIAN WAS ABLE TO CONFIRM THE RESET ALARM DURING A REVIEW OF THE EVENT TRACE LOG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752951 LTV 1000 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 1000

    Patients

    Seq Age Sex Outcome Treatment
    1