BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA1000

    MDR report key: 1160631 · Received September 1, 2008

    Report

    Report Number
    3004526608-2008-00065
    Event Type
    Malfunction
    Date Received
    September 1, 2008
    Date of Event
    July 26, 2008
    Report Date
    July 26, 2007
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Removal / Correction Number
    3004526608-5/6/08-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 FACILITY IN APRIL 2008.

    Description of Event or Problem · 1

    AFTER THE EXAM WAS COMPLETED AND TRANSFERRED TO PICTURE ARCHIVING & COMMUNICATION SYS (PACS) IT WAS REPORTED THAT THE PACS SCAN CHANGED THE TIME IN THE STUDY DATE/TIME BUT NOT THE DATE ITSELF DURING THIS PROCESS. THIS CHANGE IS THEN TRANSMITTED TO PACS. NO INJURY OR MISDIAGNOSIS WAS REPORTED. THE INCORRECT STUDY DATE/TIME CAN CAUSE CONFUSION IN ORDINARY PRACTICE WHERE BY A PT'S IMAGES CAN BE PERCEIVED TO BE NEWER THAN THEY REALLY ARE AND LEAD TO IMPROPER CLINICAL DECISIONS.

    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