BEUDAMED
    FDA Adverse Event Death Summary report: N

    LTV 1000 VENTILATOR

    MDR report key: 7606798 · Received June 15, 2018

    Report

    Report Number
    2031702-2018-02209
    Event Type
    Death
    Date Received
    June 15, 2018
    Date of Event
    July 30, 2017
    Report Date
    June 15, 2018
    Manufacturer
    VYAIRE MEDICAL, INC
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED INCIDENT WAS REPORTED TO VYAIRE MEDICAL FROM A RESEARCH COMPANY. THE REPORTED INCIDENT WAS REPORTED TO HAVE OCCURRED ON (B)(6) 2017. VYAIRE MEDICAL HAS NO RECORD OF THIS REPORTED ISSUE AND DID NOT RECEIVE THE SUSPECT DEVICE FOR EVALUATION. THE REPORTED INCIDENT HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO VYAIRE MEDICAL THAT A PATIENT PASSED AWAY ON AN LTV 950 VENTILATOR. THE CUSTOMER CLAIMS THAT THE VENTILATOR DID NOT ALARM WHEN THE PATIENT WAS DISCONNECTED FROM THE VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450113 LTV 1000 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK VYAIRE MEDICAL, INC LTV 950

    Patients

    Seq Age Sex Outcome Treatment
    1 Death