BEUDAMED
    FDA Adverse Event Death Summary report: N

    BRILLIANCE ICT

    MDR report key: 1821413 · Received August 24, 2010

    Report

    Report Number
    1525965-2010-00023
    Event Type
    Death
    Date Received
    August 24, 2010
    Date of Event
    April 7, 2010
    Report Date
    April 7, 2010
    Manufacturer
    PHILIPS MEDICAL SYSTEMS (CLEVELAND)
    Product Code
    JAK
    PMA / PMN Number
    K060937
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HOSPITAL CONFIRMED THAT UPON REVIEW OF THE CT IMAGES, THE RADIOLOGIST DETERMINED THAT NO LIFE-SUSTAINING MEASURES COULD BE TAKEN. THE HOSPITAL STATED THAT THIS OUTCOME WOULD NOT HAVE BEEN AFFECTED BY RECEIPT OF A MORE TIMELY SCAN. THE PHILIPS CT SCANNER DID NOT CAUSE OR CONTRIBUTE TO THIS PATIENT'S DEATH. THE EXACT CAUSE OF THE ALLEGED LONG SCAN TIME COULD NOT BE DETERMINED. A SYSTEM GENERATED REPORT ANALYZED BY PHILIPS DID NOT SHOW ANY SYSTEM PROBLEMS THAT CAUSED SCAN DELAY. ANALYSIS DID IDENTIFY SOME OPERATOR WORKFLOW RELATED DELAYS. THERE WAS ALSO NOTED SLOWNESS IN THE HOSPITAL'S NETWORK AT THE TIME. IN ADDITION, IT IS EXPECTED THAT INITIALIZATION OF THE SYSTEM WILL TAKE APPROXIMATELY 30 MINUTES. AS EXPLAINED IN THE IFU, SECTION 7.2.2 SYSTEM POWER-UP (IF SYSTEM IS OFF MORE THAN 30 MINUTES) STEP 7 STATES THAT .... "IF THE SYSTEM HAS BEEN POWERED DOWN (COLD STARTUP) FOR MORE THAN 4 HOURS, PLEASE WAIT 30 MINUTES FOR X-RAY DETECTOR THERMAL STABILIZATION BEFORE PROCEEDING..." THE NEED FOR THIS MDR WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINTS. (B)(4).

    Description of Event or Problem · 1

    PHILIPS MEDICAL ((B)(4)) WAS NOTIFIED OF A PATIENT DEATH FOLLOWING A CT SCAN CONDUCTED ON A PATIENT AT THE CLINICAL CENTER OF THE UNIVERSITY OF (B)(6). A PATIENT WAS HOSPITALIZED AFTER FALLING FROM THE SIXTH FLOOR OF A BUILDING. IT WAS REPORTED THAT THE PATIENT WAS GIVEN A CT SCAN WHICH LASTED APPROXIMATELY 30 MINUTES. THE DOCTOR'S EXPECTATION IN AN EMERGENCY SITUATION WAS THAT THE SCAN SHOULD HAVE BEEN COMPLETED WITHIN 2 MINUTES. AFTER RECEIVING THE CT SCAN, THE PATIENT WAS TRANSPORTED AND TRANSFERRED TO ANOTHER HOSPITAL ROOM WITHIN THE EMERGENCY CENTER. THE PATIENT WAS MONITORED WITH AN ECG BUT DIED IN THE COURSE OF THE DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BRILLIANCE ICT COMPUTED TOMOGRAPHY SYSTEM JAK PHILIPS MEDICAL SYSTEMS (CLEVELAND) 728311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Death