BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIEMENS E-CAM

    MDR report key: 514206 · Received February 17, 2004

    Report

    Report Number
    MW1031308
    Event Type
    Injury
    Date Received
    February 17, 2004
    Date of Event
    January 1, 2001
    Report Date
    February 17, 2004
    Manufacturer
    SIEMENS MEDICAL SYSTEMS
    Product Code
    IYX
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    SIEMENS MEDICAL SYSTEMS QUOTE/UNQUOTE WAS UPGRADING THEIR NUCLEAR MEDICAL SYSTEMS SNAC COMPUTER SOFTWARE QUOTE/UNQUOTE. UNBENOUNCED TO THE CUSTOMERS THEY WERE DUPED INTO BELIEVING THAT IT WAS AN UPGRADE. IN FACT THEY WERE DELETING VALUABLE DIAGNOSTIC SOFTWARE FORM COMPUTER THAT DETERMINED WHETHER OR NOT THE SYSTEM WAS OPERATING CORRECTLY OR NOT. REPORTER BELIEVES THAT THIS WAS DONE WITHOUT THEIR KNOWLEDGE AND THEY WOULD LIKE DIAGNOSTIC CAPABILITIES BACK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIEMENS E-CAM NUCLEAR MEDICINE GAMMA CAMERA IYX SIEMENS MEDICAL SYSTEMS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Other| R