BEUDAMED
    FDA Adverse Event Death Summary report: N

    HISPEED CT/I

    MDR report key: 1243323 · Received November 17, 2008

    Report

    Report Number
    2126677-2008-00096
    Event Type
    Death
    Date Received
    November 17, 2008
    Date of Event
    October 14, 2008
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K964746
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GE ENGINEERING INVESTIGATION DETERMINED THAT THE SYSTEM OPERATED AS EXPECTED AND DESIGNED. NO SYSTEM MALFUNCTION EXISTS. THE INABILITY OF THE SYSTEM TO PEFORM THE SCAN WAS DUE TO PHYSICAL DAMAGE TO THE SYSTEM CONSISTING OF A BROKEN TABLE COVER LATCH, AND DISCONNECTED TABLE SAFETY SWITCH. THE DISLODGED CONNECTION PREVENTED THE SYSTEM FROM SCANNING, AS DESIGNED, UNTIL IT WAS RECONNECTED. THE SYSTEM HAD BEEN OPERATIONAL JUST PRIOR TO THE ARRIVAL OF THE PT, INDICATING THE PHYSICAL DAMAGE MAY HAVE OCCURRED JUST PRIOR TO OR DURING THIS PT'S EXAMINATION. THE PT DID RECEIVE A CT SCAN AT THE SECOND FACILITY, HOWEVER, THE RESULTS CONFIRMED THAT THE PT WAS NOT A CANDIDATE FOR ANY TREATMENT. A PRE-EXISTING PT CONDITION WAS THE CAUSE OF THE PT'S DEATH. ACCORDING TO THE MEDWATCH REPORT SUBMITTED BY THE USER FACILITY, CT DONE SHOWED MASSIVE INTRACRANIAL BLEED IN LEFT BASAL GANGLIA WHICH IS TYPICAL LOCATION FOR HYPERTENSIVE BLEED. ALL PT INJURIES DESCRIBED WERE DUE TO EVENTS OCCURING PRIOR TO THE ATTEMPTED USE OF THE CT SYSTEM. IT WAS CONFIRMED THAT THE PT DID NOT SUFFER ANY INJURY FROM THE CT SYSTEM AND THAT PRE-EXISTING INJURIES WERE NOT WORSENED BY ANY OPERATION OF THE CT SYSTEM.

    Description of Event or Problem · 1

    A MEDWATCH REPORT SUBMITTED BY A USER FACILITY TO THE FDA WAS FORWARDED TO GE HEALTHCARE INDICATING AN EVENT WHERE A PT COULD NOT BE SCANNED BY A CT SYSTEM AT THE SITE, AND EVENTUALLY DIED SEVERAL DAYS LATER AT ANOTHER FACILITY. IT WAS REPORTED THAT THE SITE WAS UNABLE TO ACQUIRE IMAGES DURING AN ATTEMPT TO SCAN AN ER PT. THE PT ARRIVED AT THE SITE IN CRITICAL CONDITION, SUFFERING FROM A PRE-EXISTING CONDITION THAT HAD THREATENED THE LIFE OF THE PT IN TRANSIT, AND PRIOR TO ARRIVING AT THE HOSP. THE PT WAS NOT ABLE TO BE SCANNED BY THE SYSTEM BECAUSE THE DISCONNECTED TABLE SAFETY SWITCH PREVENTED SYSTEM OPERATION, AS DESIGNED. THE PT WAS TAKEN TO ANOTHER FACILITY AND EXPIRED APPROX TWO DAYS LATER, DUE TO PRE-EXISTING CONDITION. IT WAS CONFIRMED WITH THE SITE THAT THE PT WAS DETERMINED TO NOT BE A CANDIDATE FOR TREATMENT, AND THAT THE INABILITY TO PERFORM THE CT SCAN DID NOT DIRECTLY CAUSE OR CONTRIBUTE TO THE OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HISPEED CT/I JAK JAK GE MEDICAL SYSTEMS, LLC 2137755 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 28 YR Death