BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV 1200 VENTILATOR

    MDR report key: 6106124 · Received November 16, 2016

    Report

    Report Number
    2031702-2016-01445
    Event Type
    Malfunction
    Date Received
    November 16, 2016
    Date of Event
    May 1, 2015
    Report Date
    November 16, 2016
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    PMA / PMN Number
    K060647
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS INCLUDED IN A TWO-YEAR RETROSPECTIVE COMPLAINT REVIEW TO ASSESS MDR REPORTABILITY COMPLIANCE. THIS COMPLAINT WAS DEEMED TO MEET THE REQUIREMENTS FOR MDR SUBMISSION AND IS THEREFORE BEING SUBMITTED TO THE FDA. (B)(4). ANY ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER WILL BE INCLUDED IN A FOLLOW UP REPORT. (B)(4). CAREFUSION THIRD PARTY SERVICE TECHNICIAN WAS ABLE TO VERIFY THE CUSTOMER'S REPORTED ISSUE. BENCH TESTING REVEALED A FAULT OXYGEN BLENDER. THE SERVICE TECHNICIAN REPLACED THE OXYGEN BLENDER AND ISSUE WAS RESOLVED. UNIT PASSED ALL TESTING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS AUTO-CYCLING DURING TESTING. THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED TO THE REPORTED EVENT

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    758697 LTV 1200 VENTILATOR VENTILATOR, CONTINUOUS, FACILITY USE CBK CAREFUSION 203, INC LTV 1200

    Patients

    Seq Age Sex Outcome Treatment
    1