BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICOM

    MDR report key: 3553997 · Received December 30, 2013

    Report

    Report Number
    MW5033669
    Event Type
    Malfunction
    Date Received
    December 30, 2013
    Date of Event
    December 26, 2013
    Report Date
    December 27, 2013
    Manufacturer
    SCIMAGE INC.
    Product Code
    LMD
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DELAY IN CARE DUE TO BUG IN SCIMAGE TELERADIOLOGY SOFTWARE, WHICH PREVENTED TIMELY TRANSMISSION OF MULTIPLE STAT RADIOLOGY EXAMS. APPLICATION IS ERRONEOUSLY REJECTING ASSOCIATIONS FROM THE FACILITY PACS DUE TO A LICENSE FILE ISSUE. BUG HAS BEEN REPORTED TO MANUFACTURER MULTIPLE TIMES WITHOUT RESOLUTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680001 PICOM PACS LMD SCIMAGE INC. PICOM NDSCOP 2.3.5.8

    Patients

    Seq Age Sex Outcome Treatment
    1 Other