BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MERGE UNITY PACS

    MDR report key: 6434929 · Received March 26, 2017

    Report

    Report Number
    2183926-2017-00076
    Event Type
    Malfunction
    Date Received
    March 26, 2017
    Report Date
    February 27, 2017
    Manufacturer
    MERGE HEALTHCARE
    Product Code
    LLZ
    PMA / PMN Number
    K041935
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TESTING AND INVESTIGATION BY MERGE SUPPORT DETERMINED THAT THE ERROR "DEVICE: AUTOLOADER 1, HID-0 ERROR CODE: 363 FAILED TO START LABEL RE-TRANSFER ON EVEREST PRINTER; PRINTER SENSE CODE = 254 (UNDEFINED SENSE CODE)" WAS LIKELY RELATED TO THE LABEL/RIBBON ASSEMBLY. THE CUSTOMER FOUND THAT THE COLOR RIBBON (A PART OF THE LABEL/RIBBON ASSEMBLY) WAS OUT. ONCE THE COLOR RIBBON WAS CHANGED, THE ISSUE WAS RESOLVED. A REVIEW OF THE MERGE UNITY USER GUIDES DID NOT REVEAL ANY TROUBLESHOOTING OR OTHER ANOMALIES/ISSUES REGARDING BURNING IMAGES ONTO A CD. A REVIEW OF THE COMPLAINT HISTORY INDICATES THERE IS NO SIGNIFICANT TREND. TRENDING WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    MERGE UNITY PACS, A MEDICAL IMAGE AND INFORMATION MANAGEMENT SYSTEM THAT IS USED FOR VIEWING, SELECTION, PROCESSING, PRINTING, TELECOMMUNICATIONS, AND MEDIA INTERCHANGE OF MEDICAL IMAGES FROM A VARIETY OF DIAGNOSTIC IMAGING SYSTEMS. ON (B)(4) 2017, MERGE WAS NOTIFIED THAT ON AN UNSPECIFIED DATE OVER THE WEEKEND OF (B)(6), AN ERROR WAS RECEIVED WHEN ATTEMPTING TO BURN IMAGES ONTO A COMPACT DISC (CD). THE CUSTOMER WAS NOT ABLE TO BURN IMAGES OF A COMPUTED TOMOGRAPHY (CT) OF THE HEAD/NECK ONTO A CD FROM THEIR RIMAGE BURNER, WHICH WAS NEEDED FOR A PATIENT BEING AIR-LIFTED TO ANOTHER FACILITY. A PATIENT WAS BEING EVALUATED IN THE EMERGENCY DEPARTMENT FOR AN ATTEMPTED SUICIDE. IT WAS REPORTED THAT THE PATIENT WAS UNRESPONSIVE AND INTUBATED. THE CUSTOMER REPORTED THAT THE PATIENT WAS AIR LIFTED TO A PEDIATRIC TRAUMA CENTER IN LUBBOCK, TX IN GRAVE CONDITION. AS A RESULT OF THE CUSTOMER NOT BEING ABLE TO BURN IMAGES ONTO THE CD, THE CUSTOMER REPORTED THAT ANOTHER CT HAD TO BE PERFORMED AT THE HOSPITAL RECEIVING THE PATIENT. THERE WERE NO KNOWN ADVERSE EVENTS TO THE PATIENT. HOWEVER, HAVING TO RE-DO A CT OF THE HEAD/NECK CAN DELAY PATIENT CARE AND/OR DIAGNOSIS. IN ADDITION, THIS CAN EXPOSE THE PATIENT TO ADDITIONAL UNNECESSARY RADIATION. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    217081 MERGE UNITY PACS PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM LLZ MERGE HEALTHCARE UNITY PACS R11.0.455.12641

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR