BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 7726302 · Received July 27, 2018

    Report

    Report Number
    2031702-2018-03017
    Event Type
    Death
    Date Received
    July 27, 2018
    Date of Event
    June 27, 2018
    Report Date
    July 25, 2018
    Manufacturer
    VYAIRE MEDICAL
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    VYAIRE MEDICAL COMPLAINT NUMBER: (B)(4). RESULTS OF INVESTIGATION: VYAIRE MEDICAL WAS NOT ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE DURING TESTING AND EVALUATION. THE VENTILATOR WAS TESTED WITH A KNOWN GOOD AC ADAPTER AND KNOWN GOOD PATIENT CIRCUIT CONNECTED. THE VENTILATOR PASSED 303 HOURS OF EXTENDED TESTS AT THE CUSTOMER'S SETTINGS. THE VENTILATOR PASSED THE TROUBLESHOOTING FINAL TEST WHICH INCLUDES MANY ALARM AND VENTILATION FUNCTIONS. THE DEVICE PASSED ALL TESTING AND MET ALL VYAIRE MANUFACTURER SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT THE VENTILATOR DID NOT ALARM WHEN THE PATIENT PASSED AWAY. THE CUSTOMER IS REQUESTING AN EVENT TRACE DOWNLOAD TO BE PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568901 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Death