BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SIEMENS E-SOFT WORKSTATION

    MDR report key: 1760750 · Received July 13, 2010

    Report

    Report Number
    MW5016730
    Event Type
    Malfunction
    Date Received
    July 13, 2010
    Report Date
    July 13, 2010
    Manufacturer
    SIEMENS
    Product Code
    LNX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    WE HAVE THREE SIEMENS E. SOFT DEVICES, A WORKSTATION SMS, WORKSTATION AND SIGNATURE E.CAM DUAL CAMERA. THESE DEVICES HAVE CRITICAL WINDOWS VULNERABILITIES. SIEMENS HAS CITED FDA REGULATIONS AS THE REASON THAT THEY CAN NOT PATCH THESE VULNERABILITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS E-SOFT WORKSTATION ESOFT LNX SIEMENS
    2 SIEMENS E-SOFT CAMERA ESOFT LNX SIEMENS

    Patients

    Seq Age Sex Outcome Treatment
    1