BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA1000

    MDR report key: 1160632 · Received September 1, 2008

    Report

    Report Number
    3004526608-2008-00064
    Event Type
    Malfunction
    Date Received
    September 1, 2008
    Date of Event
    July 10, 2007
    Report Date
    July 10, 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 Location
    SN
    Reporter Occupation
    NOT APPLICABLE

    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 THE 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 PICTRUE ARCHIVING & COMMUNICATION SYS LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK