BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LTV

    MDR report key: 3914118 · Received July 3, 2014

    Report

    Report Number
    2031702-2014-00168
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Report Date
    July 3, 2014
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE EVENT TRACE REVEALED MULTIPLE TBN ESTP AND TBN HSTP ALARM CONDITIONS. THERE WERE NO ENTRIES IN THE EVENT TRACE WHICH INDICATE THE VENTILATOR SHUTDOWN OR RESET UNEXPECTEDLY. ALL OPERATIONAL PERIODS ENDED PROPERLY WITH A 3 SECOND ON/STANDBY BUTTON PRESS AS INDICATED BY THE VENT 0 ENTRIES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE VENTILATOR ALARM SILENCE BUTTON WAS PRESSED, THE VENTILATOR SHUT DOWN. THE VENTILATOR ALARMS WITHOUT DISPLAYING THE ALARM. IT IS UNKNOWN IF THE VENTILATOR WAS CONNECTED TO A PATIENT WHEN THE REPORTED PROBLEM OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391847 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1