BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CENTRICITY PACS

    MDR report key: 1298020 · Received December 9, 2008

    Report

    Report Number
    3004526608-2008-00094
    Event Type
    Malfunction
    Date Received
    December 9, 2008
    Date of Event
    November 10, 2008
    Report Date
    December 9, 2008
    Manufacturer
    GE HEALTHCARE INTEGRATED IT SOLUTIONS
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GE REPRESENTATIVE EVALUATED THE ISSUE AT THE CUSTOMER SITE AND WHILE THE ISSUE COULD BE DUPLICATED AT THE FACILITY, THE ISSUE COULD NOT BE DUPLICATED IN THE LAB WITH SIMILAR SYSTEMS. A GE CLINICAL APPLICATIONS SPECIALIST WILL MONITOR THIS FACILITY FOR FURTHER ISSUES AND FURTHER INVESTIGATION OF THIS GLITCH BY GE HEALTHCARE ENGINEERS IS ON-GOING. THERE WAS NO PATIENT INJURY ASSOCIATED WITH THIS EVENT. THIS SYSTEM IS BEING MONITORED AND REMAINS IN USE AT THE FACILITY.

    Description of Event or Problem · 1

    WHEN REJECTING IMAGES, THE IMAGES ARE REJECTED FROM ANOTHER (ALTHOUGH DUPLICATE) STUDY, THAT IS AT THE VERIFIED STATUS OR ABOVE, CAUSING IMAGES TO NO LONGER BE AVAILABLE FOR INTERPRETATION OR REVIEW WITHOUT THE KNOWLEDGE OF THE END USER. ISSUE MAY CAUSE UNINTENTIONAL DATA LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CENTRICITY PACS RA1000 LLZ GE HEALTHCARE INTEGRATED IT SOLUTIONS RA1000 NA

    Patients

    Seq Age Sex Outcome Treatment
    1