BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEFINIUM 8000

    MDR report key: 6023361 · Received October 12, 2016

    Report

    Report Number
    2126677-2016-00015
    Event Type
    Injury
    Date Received
    October 12, 2016
    Date of Event
    May 27, 2016
    Report Date
    September 12, 2016
    Manufacturer
    WSO GE MEDICAL SYSTEMS, LLC
    Product Code
    KPR
    PMA / PMN Number
    K051967
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. ATTEMPTS TO COLLECT THIS INFORMATION ARE BEING COMPLETED WITH THE USER FACILITY. DEVICE EVALUATED BY USER FACILITY. DATE OF DEVICE MANUFACTURE IS CURRENTLY UNKNOWN AS THE DEVICE SYSTEM IDENTIFICATION NUMBER WAS NOT PROVIDED. GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. ATTEMPTS TO COLLECT THIS INFORMATION ARE BEING COMPLETED WITH THE USER FACILITY. DEVICE EVALUATED BY USER FACILITY. DATE OF DEVICE MANUFACTURE IS CURRENTLY UNKNOWN AS THE DEVICE SYSTEM IDENTIFICATION NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    GE HEALTHCARE¿S INVESTIGATION HAS COMPLETED AND THE CAUSE OF THIS EVENT WAS IDENTIFIED AS A COMBINATION OF HARDWARE WEAR AND USER ERROR. ALL SERVICE ACTIVITIES FOR THIS SITE ARE COMPLETED BY IN-HOUSE BIOMEDICAL ENGINEERS. UPON COMMUNICATION WITH THE IN-HOUSE BIOMED TEAM, IT WAS DETERMINED THE WALL STAND GAS SPRING WAS WORN CAUSING THE WALL STAND TO TILT FASTER THAN EXPECTED WHEN THE LOCKS WERE RELEASED. THE GAS SPRING WAS REQUESTED TO BE RETURNED TO GE HEALTHCARE BUT THE IN-HOUSE BIOMED TEAM CONFIRMED THEY DISCARDED ALL PARTS. THEY DID CONFIRM THEY REPLACED THE GAS SPRING TO CORRECT THE ISSUE. IN ADDITION, THE USER WAS ALSO MADE AWARE TO REMOVE THE LATERAL BAR AND CLEAR PATIENTS FROM THE WALL STAND WHEN CONDUCTING THE TILTING OPERATION AS STATED IN THE OPERATOR¿S MANUAL. NO FURTHER ACTIONS ARE REQUIRED. CORRECTED DATA: UPON FURTHER FOLLOW UP WITH THE USER FOR ADDITIONAL DETAILS REGARDING THIS INCIDENT, IT WAS DISCOVERED THE ORIGINAL INJURY THAT OCCURRED WAS INCORRECTLY REPORTED. THE ORIGINAL INFORMATION RECEIVED BY THE USER STATED THE TECHNOLOGIST WAS DIAGNOSED WITH A RIGHT CLAVICLE FRACTURE AND TENDONITIS OF TWO MAIN MUSCLES WHEN IN FACT THE ER DIAGNOSIS REPORT WAS CONFIRMED AS AN ¿UNSPECIFIED SOFT TISSUE RIGHT SHOULDER AND UPPER ARM INJURY TREATED WITH ICE APPLICATION¿ WHICH IS CONSIDERED MINOR. DEVICE EVALUATED BY USER'S IN-HOUSE BIOMEDICAL ENGINEER. GE HEALTHCARE¿S INVESTIGATION HAS COMPLETED AND THE CAUSE OF THIS EVENT WAS IDENTIFIED AS A COMBINATION OF HARDWARE WEAR AND USER ERROR. ALL SERVICE ACTIVITIES FOR THIS SITE ARE COMPLETED BY IN-HOUSE BIOMEDICAL ENGINEERS. UPON COMMUNICATION WITH THE IN-HOUSE BIOMED TEAM, IT WAS DETERMINED THE WALL STAND GAS SPRING WAS WORN CAUSING THE WALL STAND TO TILT FASTER THAN EXPECTED WHEN THE LOCKS WERE RELEASED. THE GAS SPRING WAS REQUESTED TO BE RETURNED TO GE HEALTHCARE BUT THE IN-HOUSE BIOMED TEAM CONFIRMED THEY DISCARDED ALL PARTS. THEY DID CONFIRM THEY REPLACED THE GAS SPRING TO CORRECT THE ISSUE. IN ADDITION, THE USER WAS ALSO MADE AWARE TO REMOVE THE LATERAL BAR AND CLEAR PATIENTS FROM THE WALL STAND WHEN CONDUCTING THE TILTING OPERATION AS STATED IN THE OPERATOR¿S MANUAL. NO FURTHER ACTIONS ARE REQUIRED. CORRECTED DATA: UPON FURTHER FOLLOW UP WITH THE USER FOR ADDITIONAL DETAILS REGARDING THIS INCIDENT, IT WAS DISCOVERED THE ORIGINAL INJURY THAT OCCURRED WAS INCORRECTLY REPORTED. THE ORIGINAL INFORMATION RECEIVED BY THE USER STATED THE TECHNOLOGIST WAS DIAGNOSED WITH A RIGHT CLAVICLE FRACTURE AND TENDONITIS OF TWO MAIN MUSCLES WHEN IN FACT THE ER DIAGNOSIS REPORT WAS CONFIRMED AS AN ¿UNSPECIFIED SOFT TISSUE RIGHT SHOULDER AND UPPER ARM INJURY TREATED WITH ICE APPLICATION¿ WHICH IS CONSIDERED MINOR.

    Description of Event or Problem · 1

    DURING A LATERAL CHEST X-RAY AT THE WALL STAND, THE PATIENT POSITIONED THEIR HANDS ON THE LATERAL SUPPORT BAR. AT THAT TIME, THE DETECTOR MOVED TO A -2 DEGREE POSITION, SO IN ORDER TO MOVE THE DETECTOR INTO AN UPRIGHT POSITION WHERE IT WOULD SHOOT THAT IMAGE, THE EMPLOYEE ASKED THE PATIENT TO MOVE JUST A LITTLE BIT, GRABBED THE RELEASE BAR AND BRACED IT WITH THE EMPLOYEE'S RIGHT HAND AS WHAT'S NORMALLY DONE TO MOVE IT BACK INTO A 0 DEGREE PLACEMENT. AT THAT TIME, THE DETECTOR MOVED FORWARD AND THE LATERAL BAR CAME DOWN ON THE PATIENT'S HEAD, AND THE EMPLOYEE CAUGHT THE BRUNT OF THE FORWARD MOTION ON THE EMPLOYEE'S ARM. THERE WAS NO INJURY TO THE PATIENT, BUT THE EMPLOYEE'S SHOULDER IS NOW HURT AND IS BEING SEEN BY EMPLOYEE HEALTH. THE EMPLOYEE WAS LATER DIAGNOSED WITH A FRACTURED CLAVICLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672466 DEFINIUM 8000 STATIONARY X-RAY SYSTEM KPR WSO GE MEDICAL SYSTEMS, LLC NA 100172WG6

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention