BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 4900148 · Received July 8, 2015

    Report

    Report Number
    2031702-2015-00126
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEM. THE VENTILATOR PASSED AN EXTENDED TEST RUN USING THE CUSTOMER¿S VENTILATOR SETTINGS. THE VENTILATOR PASSED THE LTV FINAL TEST WHICH INCLUDES MANY VENTILATION AND ALARM FUNCTIONS. THE VENTILATOR IS NOT DESIGNED TO ALARM FOR A DISC/SENSE CONDITION WHEN THE PATIENT CIRCUIT IS DISCONNECTED DOWNSTREAM FROM THE PATIENT CIRCUIT WYE. PER THE OPERATOR'S MANUAL, THE DISC/SENSE ALARM DETECTS WHEN THE PATIENT CIRCUIT WYE ¿SENSE LINES¿ ARE NOT CONNECTED TO THE VENTILATOR. IT IS NOT DESIGNED TO DETECT A ¿PATIENT DISCONNECT¿ CONDITION. AS LONG AS DOWNSTREAM FLOW IS DETECTED THROUGH THE PATIENT CIRCUIT WYE, NO DISC/SENSE ALARM CONDITION WILL BE ISSUED. THE ¿LOW PRESSURE¿ AND ¿LOW MINUTE VOLUME¿ ALARM SETTINGS, WHEN SET APPROPRIATELY, ARE PROVIDED TO DETECT THE ABSENCE OF PROPER PATIENT VENTILATION. THE EVENT TRACE DID NOT CONTAIN ANY UNUSUAL ALARM TYPES OR INCIDENT COUNTS. ALL EVENT TRACE ENTRIES ARE CONSISTENT WITH NORMAL VENTILATOR OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE VENTILATOR DID NOT ALARM WHEN THE CIRCUIT WAS DISCONNECTED. THE REPORTED EVENT OCCURRED TWICE. IT IS UNKNOWN IF THE PATIENT CIRCUIT WAS DISCONNECTED AT THE PATIENT WYE OR AT THE VENTILATOR. NO PATIENT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443870 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1