BEUDAMED
    FDA Adverse Event Death Summary report: N

    CENTRICITY RA1000

    MDR report key: 984851 · Received January 25, 2008

    Report

    Report Number
    3004526608-2008-00003
    Event Type
    Death
    Date Received
    January 25, 2008
    Date of Event
    December 1, 2007
    Report Date
    December 28, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED ISSUE IS CURRENTLY UNDER INVESTIGATION. ADDITIONAL DETAILS REGARDING THE EVENT INCLUDING A CONFIRMED DATE/TIME OF DEATH, CAUSE OF DEATH, PT IDENTIFIERS AND MORE INFO ABOUT THE EVENTS LEADING UP TO THE SITUATION HAVE BEEN REQUESTED FROM THE REPORTING SITE. THE SITE HAS ATTRIBUTED THE CAUSE OF THE EVENT TO A TECHNOLOGIST INCORRECTLY LABELING THE KODAK CR CASSETTE WITH ANOTHER PT'S NAME AT THE PT'S BEDSIDE. THE SITE HAS NOT INDICATED THERE WAS ANY FAILURE OF THE GE PACS SYSTEM TO PERFORM AS DESIGNED. THE DATA WAS REPORTEDLY DISPLAYED AND HANDLED PROPERLY WITHIN THE PACS SYSTEM, BUT DUE TO HUMAN ERROR WAS INCORRECTLY ENTERED INTO THE SYSTEM, AND THE ERROR WAS APPARENTLY NOT IDENTIFIED DURING USER VERIFICATION STEPS PRIOR TO BEING INPUT INTO THE PACS SYSTEM. GE HAS OFFERED IT'S ASSISTANCE IN ANY FURTHER INVESTIGATION OF THE EVENT THAT THE SITE MAY NEED INCLUDING REVIEWING THE CONFIGURATION AND/OR USAGE HISTORY OF THEIR PACS SYSTEM. GE HAS ALSO NOTIFIED KODAK OF THIS EVENT. SHOULD ADDITIONAL INFO BE ACQUIRED, A FOLLOW UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A TECHNOLOGIST PERFORMED A PORTABLE X-RAY EXAM AT A PT'S BEDSIDE USING A KODAK COMPUTER RADIOGRAPHY SYSTEM. THE FACILITY REPORTED THAT THEY MISTAKENLY LABELED THE WRONG PT NAME ON THE CASSETTE AT THE BEDSIDE, AND SUBSEQUENTLY UPLOADED THE SAME INCORRECT INFO TO THE GE CENTRICITY PACS SYSTEM. THE STUDY WAS MISTAKENLY LOADED INTO THE PACS SYSTEM UNDER A MALE PT'S NAME (INSTEAD OF THE FEMALE PT THE EXAM WAS CONDUCTED ON). WHEN THE IMAGE WAS SUBSEQUENTLY REVIEWED USING GE'S PACS SYSTEM, IT WAS ASSOCIATED WITH THE MALE PT INSTEAD OF THE CORRECT FEMALE PT. THE MALE PT (WHOM THE IMAGING STUDY WAS NOT INTENDED FOR) REPORTEDLY RECEIVED AN INCORRECT DIAGNOSIS AS A RESULT OF THE PRECEDING EVENTS. THIS SITUATION RESULTED IN A TUBE BEING PLACED DOWN THE PT'S THROAT, WHICH REPORTEDLY CONTRIBUTED TO HIS DEATH. THE CIRCUMSTANCES SURROUNDING HIS DEATH ARE UNK AT THIS TIME AND AN INVESTIGATION IS ONGOING. THE FACILITY REPORTED THAT THE PACS SYSTEM CORRECTLY DISPLAYED THE INFO THAT WAS PROVIDED TO IT, BUT DUE TO USER ERROR IN UPLOADING THE INCORRECT INFO, IT WAS FOR THE WRONG PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY RA1000 PICTURE ARCHIVING & COMMUNICATION SYS. LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Death KODAK CR SYSTEM| KODAK PORTABLE X-RAY