BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GC80

    MDR report key: 6661103 · Received June 22, 2017

    Report

    Report Number
    3004938766-2017-00007
    Event Type
    Injury
    Date Received
    June 22, 2017
    Date of Event
    May 23, 2017
    Report Date
    June 22, 2017
    Manufacturer
    SAMSUNG ELECTRONICS CO., LTD.
    Product Code
    KPR
    UDI-DI
    08806086403467
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYSTEM WAS FULLY VERIFIED TO BE IN GOOD WORKING CONDITION PER MANUFACTURING SPECIFICATIONS BY A RESPECTIVE FIELD SERVICE ENGINEER. THE INJURY WAS DUE TO NOT FOLLOWING THE CORRECT PROTOCOLS AND THE SYSTEM WAS FUNCTIONING PROPERLY. THE FIELD SERVICE REP WAS NOT ABLE TO DUPLICATE THIS ISSUE. FIELD SERVICE INSPECTED THE SYSTEM ON SITE - CHECKED PUI KEY, REMOTE CONTROLLER, STAND SIDE KEY AND COLLIMATOR KEY. ALSO EXAMINED THE WALL STAND FOOT PEDAL AND FOUND NO ISSUES.

    Description of Event or Problem · 1

    DURING AN L-SPINE FERGUSON AT THE WALL STAND, A SEATED EXAM, THE TUBE HEAD DID NOT STOP AND HIT THE PATIENT'S KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440921 GC80 DIGITAL RADIOGRAPHY GC80 KPR SAMSUNG ELECTRONICS CO., LTD. GC80 08806086403467

    Patients

    Seq Age Sex Outcome Treatment
    1 Other