BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 8564545 · Received April 30, 2019

    Report

    Report Number
    2031702-2019-03226
    Event Type
    Malfunction
    Date Received
    April 30, 2019
    Date of Event
    April 3, 2019
    Report Date
    April 3, 2019
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    UDI-DI
    00845873002726
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. RESULTS OF INVESTIGATION: A VYAIRE FAILURE ANALYSIS LAB TECHNICIAN WAS UNABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. THE DEVICE PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS. A REVIEW OF THE EVENT TRACE DOWNLOADED INDICATED 1 LN VENT 1 ERROR. AS A PRECAUTION, THE TECHNICIAN REPLACED THE POWER BOARD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE THAT THE LAP TOP VENTILATOR 1150 SHUT DOWN MULTIPLE TIMES. AT THIS TIME, IT IS UNKNOWN IF THERE WAS ANY PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358315 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL LTV 1150 00845873002726

    Patients

    Seq Age Sex Outcome Treatment
    1