BEUDAMED
    FDA Adverse Event Other Summary report: N

    DST-XL

    MDR report key: 3522592 · Received November 29, 2013

    Report

    Report Number
    2126677-2013-00022
    Event Type
    Other
    Date Received
    November 29, 2013
    Date of Event
    October 31, 2011
    Report Date
    October 31, 2011
    Manufacturer
    SMV INTERNATIONAL
    Product Code
    KPS
    PMA / PMN Number
    K942837
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED. A COMPLAINT WAS RECEIVED BY GHEC IN 2011 WITH AN ALLEGATION THAT A PATIENT WAS HIT ON THE LEGS WHILE BEING SCANNED WITH ADST-XL SYSTEM. GE HEALTHCARE MADE SEVERAL ATTEMPTS AT THE TIME TO OBTAIN ADDITIONAL INFORMATION FROM THE HOSPITAL, BUT NO CLARIFYING INFORMATION REGARDING THE INCIDENT AND/OR RELATIONSHIP TO THE SMV DEVICE COULD BE OBTAINED. SINCE THE FACILITY WAS NOT PROVIDING INFORMATION RELATIVE TO THE PATIENT, THERE WAS NO CONFIRMATION THAT AN INJURY OCCURRED. THE COMPLAINT WAS INVESTIGATED FOR DEVICE MALFUNCTION. DURING A WHOLE BODY (WB) BONE SCAN AT END OF THE ANTERIOR SCAN THE CAMERAS STARTED ROTATING COUNTER CLOCKWISE AND HIT THE PATIENT'S LEGS, THE TECHNICIAN IN THE ROOM STOPPED THE MOTIONS ON THE ACQUISITION SCREEN BY HITTING STOP. GE HEALTHCARE'S INVESTIGATION CONDUCTED IN 2011 FOUND DAMAGE TO THE HAND CONTROL CABLE AT THE BOOM CONNECTION, THE DAMAGE WAS DUE TO THE BOOM BEING DRIVEN TOWARDS THE WALL. IF THE WALL IS TOO CLOSE TO THE GANTRY THE BOOM WILL DRIVE INTO THE WALL. THE SYSTEM IS CLOSER TO THE WALL THAN GE RECOMMENDS (GE 735380 REV B PAGE 22, SECTION 1.9 INDICATES RAILS TO WALL ON EITHER SIDE SHOULD BE AT MINIMUM 600 MM(23.62)). THE HOSPITAL INDICATED THAT THE HAND CONTROL BUTTONS WERE NOT WORKING PROPERLY PRIOR TO THE INCIDENT AND THEY CONTINUED TO USE THE SYSTEM. THREE ROOT CAUSES WERE IDENTIFIED: HAND CONTROL CABLE DAMAGE; NEW ROOM LAYOUT (DONE BY NON-GE SERVICE) DID NOT MEET GE HEALTHCARE'S RECOMMENDATIONS, AND CAUSED THE DAMAGE TO THE HAND CONTROL CABLE; INEXPERIENCE OF THE OPERATING TECHNICIAN WHICH HAD NOT RUN A WB SCAN ON THIS SYSTEM PRIOR. THE FOLLOWING CORRECTIONS WERE MADE AT THE SITE: REPLACE THE HAND CONTROL AND ITS CABLE; ADJUST BOOM SWING TO MINIMIZE ABILITY TO DRIVE BOOM INTO THE WALL; TRAIN TECHNICIAN WHO WAS OPERATING THE CAMERA ON WB SCANNING AND HOW TO RECOVER FROM EMERGENCY CONDITIONS LIKE A COLLISION.

    Description of Event or Problem · 1

    GE HEALTHCARE'S LEGAL DEPARTMENT WAS NOTIFIED ON (B)(6) 2013 THAT A PATIENT WAS INJURED WHILE BEING SCANNED WITH A DST-XL SYSTEM, BUT NO ADDITIONAL DETAILS REGARDING THE EXTENT OF THE INJURY WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621966 DST-XL SYSTEM, TOMOGRAPHY, COMPUTED, EMISSION KPS SMV INTERNATIONAL

    Patients

    Seq Age Sex Outcome Treatment
    1