BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 4975709 · Received August 5, 2015

    Report

    Report Number
    2031702-2015-00160
    Event Type
    Injury
    Date Received
    August 5, 2015
    Date of Event
    July 2, 2015
    Report Date
    August 5, 2015
    Manufacturer
    CAREFUSION 203, INC
    Product Code
    CBK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS UNABLE TO DUPLICATE THE REPORTED PROBLEMS. 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. WHEN THE VENTILATOR WAS CONNECTED TO A TEST SPRINT PACK, THE EXTERNAL POWER AND CHARGE STATUS LED¿S WERE GREEN AFTER 20 MINUTES OF CHARGING. WHEN THE VENTILATOR WAS POWERED ON, IT VENTILATED PROPERLY FROM BOTH EXTERNAL POWER AND INTERNAL BATTERY. INTERNAL INSPECTION DID NOT REVEAL ANY ANOMALIES WITH THE VENTILATOR. A REVIEW OF THE EVENT TRACE DID NOT REVEAL ANY ABNORMAL ALARM CONDITIONS ON THE REPORTED EVENT DATE OF (B)(6) 2015. ALL EVENT TRACE ENTRIES ARE CONSISTENT WITH NORMAL VENTILATOR OPERATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN THE PATIENT WAS BEING OFF LOADED FROM THE BUS AT SCHOOL, THE NURSE NOTICED THAT THE PATIENT¿S SATURATION WAS 70% AND HR WAS 148. THE NURSE REMOVED THE VENTILATOR CIRCUIT AND NOTICED THAT THE VENTILATOR WAS OFF AND WAS NOT ALARMING. THE NURSE ALSO NOTICED THAT THE VENTILATOR DID NOT DISPLAY ANYTHING BUT THE CHARGE LIGHTS WERE STILL ON. AFTER MANUALLY VENTILATING THE PATIENT, HIS HEART RATE LOWERED TO 112 AND HIS SATURATION WAS 95%. THEY TURNED THE VENTILATOR OFF AND ON AND THE VENTILATOR STARTED TO FUNCTION AGAIN. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    515084 LTV VENTILATOR, CONTINUOUS CBK CAREFUSION 203, INC LTV 1150

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R