BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ECHOPAC WORKSTATION

    MDR report key: 4353149 · Received December 18, 2014

    Report

    Report Number
    9610482-2014-00005
    Event Type
    Malfunction
    Date Received
    December 18, 2014
    Report Date
    November 18, 2014
    Manufacturer
    GE VINGMED ULTRASOUND AS
    Product Code
    LLZ
    PMA / PMN Number
    K131685
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW UP REPORT WILL BE PROVIDED AFTER THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DUAL-MONITOR ECHOPAC WORKSTATION WITH SOFTWARE REVISION 113.0.6 MIXED REPORT MEASUREMENTS FROM THE SAME PT BUT DIFFERENT EXAM DATES. THE HOSP REPORTED THAT IF A SECOND/DIFFERENT EXAM FROM THE SAME PT IS SELECTED IN THE EXAM LIST WHILE DISPLAYING A CURRENT STUDY, AND THEN EDIT IS SELECTED, A COPY OF THE STORED REPORT MEASUREMENTS ASSOCIATED WITH THE SECOND STUDY ARE DISPLAYED ON THE SECOND MONITOR SCREEN WITHIN THE REPORT OF THE CURRENT STUDY. INFO WAS PROVIDED TO GE HEALTHCARE ENGINEERING FOR FURTHER INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    830540 ECHOPAC WORKSTATION RADIOLOGICAL IMAGE PROCESSING SYSTEM LLZ GE VINGMED ULTRASOUND AS

    Patients

    Seq Age Sex Outcome Treatment
    1