BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY WEB

    MDR report key: 1160637 · Received September 1, 2008

    Report

    Report Number
    9681779-2008-00001
    Event Type
    Malfunction
    Date Received
    September 1, 2008
    Date of Event
    January 31, 2008
    Report Date
    January 31, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION REGARDING THIS ISSUE IS BEING CONDUCTED. A FOLLOW UP MDR WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE. THIS MDR IS BEING SUBMITTED LATE, AS THIS ISSUE WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW OF COMPLAINT FILES. THIS ACTIVITY IS BEING COMPLETED AS PART OF A CORRECTIVE ACTION TAKEN PURSUANT TO AN FDA INSPECTION CONDUCTED AT THE (B) (4) FACILITY IN (B) (4) 2008.

    Description of Event or Problem · 1

    ON THE CENTRICITY WEB PRODUCT WHEN THE VIEWPORT ANNOTATION FOR PRIMARY POSITIONER ANGLE IS CONFIGURED TO BE ACTIVE IT DOES NOT SHOW THE MINUS SIGN FOR IMAGES WITH NEGATIVE VALUE. A FACILITY IDENTIFIED AN IMAGE WITH A PRIMARY POSITIONER ANGLE IN THE DICOM TAG OF -69.7 HOWEVER, THE SYSTEM SHOWED 39.7 ON THE ANNOTATION. AS A RESULT OF THIS CONDITION, THE ANGLE ASSOCIATED WITH THE POSITION OF THE IMAGE IS NOT PROPERLY REPRESENTED. THE SITUATION WAS IDENTIFIED BY THE FACILITY AND NO ADVERSE PATIENT OUTCOME WAS REPORTED TO BE ASSOCIATED WITH THIS EVENT. THE PRIMARY POSITIONER ANGLE IS NOT SHOWN BY DEFAULT IN THE CENTRICITY WEB VIEWER. HOWEVER, THIS IS A VALVE THAT CAN BE CONFIGURED TO BE SHOWN AS DESIRED BY THE ADMINISTRATOR OF THE SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY WEB ENTERPRISE WEB LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS CENTRICITY WEB NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK