BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHTSPEED

    MDR report key: 2430933 · Received January 26, 2012

    Report

    Report Number
    2126677-2012-00008
    Event Type
    Injury
    Date Received
    January 26, 2012
    Date of Event
    January 9, 2012
    Report Date
    January 13, 2012
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K013561
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS COMPLETED, NO SYSTEM MALFUNCTION WAS REPORTED OR DETERMINED TO EXIST AFTER SYSTEM TROUBLESHOOTING AND INVESTIGATION. NO ERRORS ASSOCIATED WITH THE HIS/RIS WORKLIST OR EDIT PT FUNCTION WERE FOUND AFTER REVIEW OF THE SYSTEM LOGS. GE HEALTHCARE'S INVESTIGATION OF THE SYSTEM LOGS CONFIRMED THAT TWO DISTINCT EXAMS WERE PERFORMED USING THE PT IDENTIFIERS FOR PT (B)(4). ACCORDING TO THE HOSPITAL, THIS INITIAL ERROR WAS NOTICED THE SAME DAY BY READING RADIOLOGISTS AS TWO SETS OF IMAGES WERE ASSOCIATED WITH PT (B)(4), BUT NO IMAGES WERE ASSOCIATED WITH PT (B)(4), AND THE TECHNOLOGIST WAS CONTACTED. ACCORDING TO THE EDIT AND NETWORK LOGS FROM THE SYSTEM, THE TECHNOLOGIST EDITED BOTH EXAMS, BUT MANUALLY SENT THE INCORRECT EXAM TO THE PACS SYSTEM, THAT OF PT (B)(4), WITH PT THE INFO OF PT (B)(4). THIS MODIFIED SET OF IMAGES WERE READ AND PT (B)(4) WAS DIAGNOSED AS HAVING A SKULL FRACTURE AND BLEED. PRODUCT LABELING SPECIFICALLY WARNS THE OPERATOR TO VERIFY AND RECORD THE PT'S IDENTIFICATION BEFORE STARTING A SCAN AND TO VERIFY THAT CORRECT ACCESSION NUMBER AND EXAM DESCRIPTION SELECTION IS WHAT IS DESIRED, ELSE THERE MAY BE ISSUES WITH RECONCILING EXAMS IN THE PACS SYSTEM. PT INFO IS AVAILABLE THROUGHOUT FROM SET-UP THROUGH THE EXAM COMPLETION, ALLOWING FOR FULL DETECTABILITY OF MISMATCH BETWEEN PTS, WHICH WOULD BE EXPECTED IN THIS CASE DUE TO THE DISCREPANCY IN AGE AND GENDER OF THE PTS. THE OPERATOR DOCUMENTATION PROVIDED DETAILED INSTRUCTION ON USE THE EDIT PT FEATURE AND HOW TO IDENTIFY IF AN EXAM HAS BEEN EDITED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT NAME AND DEMOGRAPHICS ANNOTATED ON CT IMAGE DATA FROM A PT (B)(4) ((B)(6); MALE) WITH A SKULL FRACTURE AND BLEED WAS ASSOCIATED WITH PT NAME AND DEMOGRAPHICS FOR PT (B)(4) ((B)(6); FEMALE) ON (B)(6) 2010 AFTER BEING SCANNED ON A LIGHTSPEED 16 CT. PT "(B)(4)" THEN SUBSEQUENTLY HAD A UNNECESSARY CRANIOTOMY PERFORMED TO REMOVE THE BLEED. ACCORDING TO THE HOSPITAL, THE PT BN IS CURRENTLY IN STABLE CONDITION AND THERE WAS NO IMPACT TO THE TREATMENT FOR PT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHTSPEED COMPUTED TOMOGRAPHY SYSTEM JAK GE MEDICAL SYSTEMS, LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other