BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY RA 1000

    MDR report key: 1338616 · Received March 6, 2009

    Report

    Report Number
    3004526608-2009-00017
    Event Type
    Malfunction
    Date Received
    March 6, 2009
    Date of Event
    January 26, 2009
    Report Date
    February 17, 2009
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    PMA / PMN Number
    K023557
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    PER THE REPORTER, THE PHYSICIAN WAS READING OUTPATIENTS AND WHILE READING ONE PATIENT, HE OPENED A PREVIOUS CXR FROM 2006 AS A REFERENCE. HE SAW A NODULE IN THE CHEST BUT HE DID NOT REALIZE THAT PACS DISPLAYED A CXR FROM ANOTHER PATIENT. THE PHYSICIAN ORDERED A CT CHEST DONE ON THE FIRST PATIENT. THE SECOND PATIENT HAD THE NODULE. THERE WAS NO REPORTED PATIENT INJURY ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY RA 1000 RA 1000 LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS 2041146-001 REV. C NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR