BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LTV

    MDR report key: 3170073 · Received June 5, 2013

    Report

    Report Number
    2031702-2013-00127
    Event Type
    Injury
    Date Received
    June 5, 2013
    Date of Event
    May 8, 2013
    Report Date
    July 9, 2013
    Manufacturer
    CAREFUSION 203, INC.
    Product Code
    CBK
    PMA / PMN Number
    K051767
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CT SCAN, THE PATIENT WAS NOT BEING VENTILATED BY THE VENTILATOR. IT IS UNK IF THE VENTILATOR HAD AN AUDIBLE ALARM WHEN THE REPORTED PROBLEM OCCURRED. THE PATIENT WAS THEN HAND VENTILATED BY BAG AND MASK. THE PATIENT WENT TO PRIMARY ARREST AND THE CARDIAC ARREST TEAM WAS SUMMONED. THE PATIENT WENT INTO SVT RHYTHM, WAS GIVEN SYNCHRONIZED SHOCK WHICH PUT THE PATIENT BACK INTO SINUS RHYTHM. THE PATIENT WAS PLACED ON ANOTHER VENTILATOR AND THE SCAN WAS RESUMED. POST SCAN THE PATIENT REMAINED STABLE AND WAS TRANSFERRED TO (B)(6). IT WAS NOTED THAT THE SPRINTPACK BATTERIES HAD FULLY DISCHARGED OVER THE TWO WEEKS WHILE THE EQUIPMENT WAS SWITCHED OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249375 LTV VENTILATOR, CONTINUOUS/CBK CBK CAREFUSION 203, INC. LTV1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R