BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTELEPACS

    MDR report key: 1214830 · Received October 27, 2008

    Report

    Report Number
    9615916-2008-00001
    Event Type
    Malfunction
    Date Received
    October 27, 2008
    Date of Event
    September 9, 2008
    Report Date
    October 27, 2008
    Manufacturer
    INTELERAD MEDICAL SYSTEMS
    Product Code
    LLZ
    PMA / PMN Number
    K070080
    Removal / Correction Number
    9615916-10/24/08-001-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL BRAND NAME: INTELEVIEWER WORKSTATION. ADDITIONAL OTHER# V.3.5.2 PI TO P56. DEVICE MANUFACTURE DATE IS THE DATE THE INTELEVIEWER MODULE WAS RELEASED FOR INCORPORATION INTO THE INTELEPACS AND INTELEVIEWER WORKSTATION PRODUCTS IN THE FIELD. WE DO NOT "MANUFACTURE" SOFTWARE SINCE WE DEPLOY REMOTELY; THEREFORE, THE DATE OF THE SOFTWARE RELEASE TO THE CUSTOMER IS THE DATE OF MANUFACTURE. THERE WAS NO PATIENT EVENT IN THIS CASE AND NONE HAVE BEEN REPORTED TO DATE, HOWEVER, THE SOFTWARE ISSUE COULD POTENTIALLY LEAD TO AN ADVERSE EVENT WHICH IS WHY THIS MDR IS BEING SUBMITTED. THE ISSUE WAS IDENTIFIED DURING A TRAINING ACTIVITY ON SITE WHERE THE SYSTEM WAS BEING USED IN A MODE UNDER WHICH THE SOFTWARE BUG MANIFESTS ITSELF.

    Description of Event or Problem · 1

    DURING AN INVESTIGATION OF AN INCIDENT REPORTED BY ONE OF INTELERAD'S FIELD PERSONNEL IN (B)(4), INTELERAD MEDICAL IDENTIFIED A SOFTWARE DEFECT IN THE SYSTEM THAT WOULD IN CERTAIN CIRCUMSTANCES PREVENT CERTAIN IMAGES FROM BEING DISPLAYED WITH NO WARNING OR ALARM TO NOTIFY THE USER OF A FAILURE. WHEN RETRIEVING IMAGES USING THE DICOM SERVICE, AND WHEN THESE IMAGES ARE PROCESSED IN A BATCH, IT IS POSSIBLE THAT THE INTELEVIEWER DATABASE ON THE WORKSTATION MAY NOT BE UPDATED AND SOME IMAGES MAY NOT BE RETRIEVED. DEPENDING ON HOW THE IMAGES ARE LOADED, THIS MAY RESULT IN EITHER THE IMAGES NOT BEING SHOWN AT ALL (I.E. INTELEVIEWER REPORTING THAT THERE ARE FEWER IMAGES IN A SERIES THAN WERE SENT BY THE SERVER), OR A DELAY IN SHOWING THE IMAGES BECAUSE THEY HAVE TO BE LOADED AGAIN. BASED ON A REVIEW OF THE POSSIBLE HEALTH HAZARDS WITH A LOCAL CUSTOMER, THERE WAS A CONCLUSION THAT SINCE THE PROBLEM COULD NOT ALWAYS BE DETECTED, THERE WAS A RISK OF A POSSIBLE MISDIAGNOSIS. THE INTELEVIEWER MODULE IS IN BOTH THE INTELEVIEWER WORKSTATION AND THE INTELEPACS PRODUCTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTELEPACS PICTURE ARCHIVING COMMUNICATION SYSTEMS LLZ INTELERAD MEDICAL SYSTEMS 3.X.X

    Patients

    Seq Age Sex Outcome Treatment
    1