BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 4763447 · Received May 1, 2015

    Report

    Report Number
    9615916-2015-00001
    Event Type
    Malfunction
    Date Received
    May 1, 2015
    Report Date
    May 8, 2015
    Manufacturer
    INTELERAD MEDICAL SYSTEMS INCORPORATED
    Product Code
    LLZ
    PMA / PMN Number
    K083520
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AFFECTED SOFTWARE VERSIONS: MODELS: 4.7.1 R27 AND UP, 4.8.1 R20 AND UP, 4.9.1 R17 AND UP, 4.10.1 R9 AND UP, 4.11.1 R3 AND UP.

    Description of Event or Problem · 1

    NO PATIENT INCIDENT REPORTED AT THIS MOMENT, THIS ISSUE IS DOCUMENTED AS A PRECAUTION. THE ISSUE WAS REPORTED BY OUR CLIENT. THEY PROVIDE TELERADIOLOGY SERVICES TO VARIOUS HOSPITALS. THEIR PROTOCOL FOR ACCEPTING STAT CASES FROM THESE HOSPITALS REQUIRES THAT THE SENDING FACILITY TRANSMIT A SEPARATE TEXT MESSAGE THAT IDENTIFIES EACH STAT CASE BY ACCESSION NO, TOGETHER WITH THE STUDY DESCRIPTION AND THE EXPECTED NUMBER OF IMAGES TO BE TRANSMITTED. FURTHER, BASED ON THIS PROTOCOL, THE CLIENT'S ADMINISTRATIVE STAFF WHO CONTROL THE WORKFLOW, CONFIRMS THE IMAGE COUNT TRANSMITTED IS THE SAME AS THE IMAGE COUNT AT THE READING CTR (IN INTELEPACS) BEFORE ACCEPTING THE CASE AND ASSIGNING TO A RADIOLOGIST FOR READING. DESCRIPTION OF PROBLEM: IMAGES SUCCESSFULLY TRANSMITTED TO INTELEPACS ARE NOT AVAILABLE FOR READING IN ALL STUDIES, AND THE READER IS UNAWARE OF THE POSSIBILITY OF MISSING IMAGES. THE PROBLEM MANIFESTS UNDER VERY SPECIFIC CIRCUMSTANCES, LIMITED TO A FEW CLIENT SITES AS A POSSIBLE PATIENT SAFETY ISSUE. THE POSSIBLE PATIENT SAFETY ARISES WHEN RECEIVING A SERIES AND CAN MANIFEST IN TWO SCENARIOS: FIRST: FOR THE 4 CLIENTS THAT EMPLOY INGEST SERVERS TO PROVIDE TEMPORARY STORE-AND-FORWARD CAPABILITIES IN THEIR ARCHITECTURE, IN SOME CONDITIONS, THESE SERVERS FAIL TO DELIVER ALL RECEIVED IMAGES TO THE PERMANENT STORAGE SERVERS AND NO RECORD OF THESE IMAGES PERSIST IN THE MAIN ARCHIVE. AS THESE INGEST SERVERS ARE NOT CONFIGURED AS VALID IMAGE LOCATIONS FOR ACCESS BY DIAGNOSTIC VIEWERS, THE STUDY CAN BE DISPLAYED IN INTELEPACS WITH LESS THAN FULL SET OF TRANSMITTED IMAGES. SECOND: FOR THE REMAINING CLIENT ARCHITECTURES THAT DO NOT EMPLOY TEMPORARY INGEST SERVERS, THERE IS STILL A VERY LOW PROBABILITY OF FAILURE (FAR LESS LIKELY THAN THE FIRST SCENARIO) FOR THE DEVICE TO PROPERLY REPLICATE AND REGISTER IMAGES WHEN TRANSFERRING THEM TO ANOTHER SERVER. IF THE SECOND COPY IS A VALID IMAGE LOCATION, IT IS POSSIBLE FOR A SOME IMAGES TO BE MISSING WHEN VIEWING. WE WILL: IMMEDIATELY VERIFY AND APPLY A BUG FIX TO ALL THE CLIENTS WHERE THIS ISSUE CAN OCCUR; APPLY AUDIT SCRIPTS TO IDENTIFY ANY OCCURRENCE OF THE ISSUE AND ALSO VALIDATE THE BUG FIX. CORRECTIVE ACTION CALENDAR: FOR THE THREE CLIENTS USING A CONFIGURATION WITH INGEST SERVERS AS TEMPORARY STORAGE, AN IMMEDIATE UPDATE PROCESS WAS UNDERTAKEN VIA THE CLIENT SPECIFIC RELEASE PROCESS (COMPLETED AS OF 04/23/2015) TO AVOID THE POSSIBILITY OF DATA LOSS. FOR THE REMAINING CLIENTS, THE NORMAL FULL RELEASE UPDATE (FRU) WILL BE EXPEDITED BUT UNDERGO THE USUAL TESTING AND RELEASE PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289277 INTELEPACS PICTURE ARCHIVING AND COMMUNICATION LLZ INTELERAD MEDICAL SYSTEMS INCORPORATED 4.7.1 R27 AND UP, 4.8.1 R20 AND UP, 4.9.1 R17 AND UP, 4.10.1 R9 AND UP, 4.11.1 R NA

    Patients

    Seq Age Sex Outcome Treatment
    1