BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDIA AND DISTRIBUTION CENTER (MDC) PACS

    MDR report key: 2033632 · Received February 11, 2011

    Report

    Report Number
    2954704-2011-00003
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    October 22, 2010
    Report Date
    February 9, 2011
    Manufacturer
    PHILIPS HEALTHCARE INFORMATICS, INC.
    Product Code
    LLZ
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MDC PACS IS A SOFTWARE APPLICATION THAT IS USED FOR RECEIVING, MANAGING, ARCHIVING, DISTRIBUTING AND RECORDING MEDICAL IMAGES ONTO PORTABLE DIGITAL MEDIA (INCLUDING BUT NOT LIMITED TO COMPACT DISK (CD) AND DVD). PRODUCT EVAL DETERMINED THE PRODUCT OPERATED AS DESIGNED. THE REPORTED MALFUNCTION HAS BEEN ASSESSED IN A HEALTH HAZARD EVAL, AND IT WAS DETERMINED THAT THE RISK IS ACCEPTABLE BASED ON ADDITIONAL ANALYSIS THAT SUPPORTS THE ISSUE OCCURRENCE AS A RESULT OF THE ACTIONS OF A SINGLE UNTRAINED INSTALLER, WHO DID NOT COMPLETELY REVIEW INSTALLATION DOCUMENTATION AND DID NOT CONFIGURE THE PRODUCT IN ACCORDANCE WITH THE SITE WORKFLOW. NO OTHER SITES WITH THIS WORKFLOW HAVE BEEN INSTALLED BY THIS UNTRAINED INSTALLER, AND NO OTHER SITES HAVE REPORTED THIS ISSUE. IF THE SYSTEM WAS MISCONFIGURED IN THIS MANNER AT A SITE THAT DOES NOT USE UNIQUE PT IDENTIFIERS, IT IS EXPECTED THAT THE ISSUE WOULD BE DETECTED QUICKLY BY THE USERS.

    Description of Event or Problem · 1

    THE PROBLEM WAS REPORTED BY THE USER SITE DURING CLINICAL USE: THE IMAGES TRANSFERRED TO THE PACS (PICTURE ARCHIVING AND COMMUNICATIONS SYSTEMS), AND ALL MR IMAGES/STUDY WERE STORED IN (B)(6) UNDER THE SAME PT NAME. UPON INVESTIGATION IT WAS DISCOVERED THAT MULTIPLE PT RECORDS WERE INCORRECTLY MERGED IN MDC PACS DUE TO A CONFIGURATION THAT DOES NOT MATCH TO THE SITE WORKFLOW. THE REPORTING SITE DOES NOT ISSUE UNIQUE PT IDENTIFIERS IN ITS WORKFLOW, ALTHOUGH THE SYSTEM WAS CONFIGURED TO USE PT ID AS A SINGLE ENTITY ATTRIBUTED FOR IDENTIFICATION OF PT ID. THERE WAS NO REPORT OF PT OR USER HARM ASSOCIATED WITH THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDIA AND DISTRIBUTION CENTER (MDC) PACS MDC PACS LLZ PHILIPS HEALTHCARE INFORMATICS, INC. R2X NA

    Patients

    Seq Age Sex Outcome Treatment
    1