BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOM POWERCONSOLE V5.16

    MDR report key: 2171278 · Received July 13, 2011

    Report

    Report Number
    MW5021385
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 13, 2011
    Manufacturer
    SCIMAGE INC
    Product Code
    LLZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Description of Event or Problem · 1

    PACS APPLICATION IS ERRONEOUSLY CHANGING THE EXAM STATUS FROM PENDING TO READ W/O A RADIOLOGIST HAVING RENDERED A REPORT. THIS ACTION TAKES THE STUDY OFF OF THE ACTIVE WORKLIST W/O THE USER BEING AWARE THAT IT STILL SHOULD BE IN THE ACTIVE QUEUE. THIS RESULTS IN SIGNIFICANT DELAYS IN INTERPRETATION, WHICH IS CRITICAL FOR STAT EXAMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICOM POWERCONSOLE V5.16 PICOM ENTERPRISE PACS LLZ SCIMAGE INC POWERCONSOLE V5.16

    Patients

    Seq Age Sex Outcome Treatment
    1