BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL

    MDR report key: 9601275 · Received January 17, 2020

    Report

    Report Number
    9601275
    Event Type
    Malfunction
    Date Received
    January 17, 2020
    Date of Event
    December 16, 2019
    Report Date
    December 31, 2019
    Manufacturer
    SST GROUP, INC.
    Product Code
    LMB
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    DISK BURNERS DO NOT WORK IN A TIMELY MATTER. RADIOLOGY WAS NOT GIVEN ENOUGH NOTIFICATION FROM THE ED TO GET A DISK MADE FOR THE PATIENT BEING TRANSFERRED OUT TO ANOTHER HOSPITAL. THERE WAS DOWN TIME FOR DAYS, SO NO IMAGES COULD BE PUSHED. WHILE TROUBLESHOOTING THE DISK BURNERS, THE PATIENT LEFT THE HOSPITAL WITHOUT ANY IMAGES. THIS COULD RESULT IN A PATIENT NEEDED TO BE RE-IMAGED AGAIN AT THE NEXT HOSPITAL AND CHARGED AGAIN FOR THE SAME EXAMS ALL BECAUSE COMMUNICATION COULD NOT BE GIVEN IN A MORE APPROPRIATE AMOUNT OF TIME. FROM THE SYSTEMS ANALYST: THE ISSUE IS WITH THE GROUP POLICY THAT THE HOSPITAL APPLIES TO THE COMPUTER. IT DISCONNECTS THE BURNER DRIVES FROM THE COMPUTER WHEN GROUP POLICY IS UPDATED. CURRENTLY WE HAVE INFORMATION TECHNOLOGY AND GROUP POLICY STAFF WORKING ON A SOLUTION. WE HAVE "EXPERIMENTED" WITH SEVERAL FIXES WITHOUT RESOLUTION. SST GROUP HAS BEEN CONTACTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65861 DEVICE, DIGITAL IMAGE STORAGE, RADIOLOGICAL LMB SST GROUP, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1