BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REVOLUTION CT

    MDR report key: 8584604 · Received May 6, 2019

    Report

    Report Number
    2126677-2019-00003
    Event Type
    Injury
    Date Received
    May 6, 2019
    Date of Event
    January 17, 2019
    Report Date
    July 19, 2019
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    PMA / PMN Number
    K133705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    THREE FIELD ENGINEERS WERE UPGRADING A MERC80 DETECTOR TO A MERC160 DETECTOR. WHILE REMOVING THE OLD DETECTOR, THE DETECTOR SLID IN THE JIB CRANE AND HIT ONE OF THE FE¿¿S ON THE TOP OF THE HEAD, SUSTAINING A SUBDURAL HEMATOMA. THERE WERE TWO ROOT CAUSES THAT WERE IDENTIFIED THAT LED TO THE INJURY TO THE FIELD ENGINEER. IMPROPER DESIGN OF THE JIB CRANE ASSEMBLY: THE JIB CRANE WAS DESIGNED TO ENSURE THAT THE ANGLE OF THE ARM WHEN PRELOADED WOULD BE 0 DEGREES. THIS WOULD ENSURE THAT THE HOIST AND DETECTOR WOULD NOT BE ABLE TO SLIDE FREELY WHEN INSIDE OF THE JIB ARM. HOWEVER, WHEN ATTACHED THE MAST ON THE GANTRY, THE PRELOADED JIB ANGLE WAS LESS THAN 0 DEGREES WHICH COULD ALLOW THE DETECTOR TO SLIDE FREELY. INCOMPLETE DEINSTALLATION DETAIL: THE PROCEDURE PROVIDES GREAT DETAIL IN THE TEXT OF HOW TO REMOVE THE DETECTOR FROM THE GANTRY AND PLACE IT ONTO THE DETECTOR SLED. HOWEVER, KEY PICTURES WERE MISSING WHICH WOULD PROVIDE IMPORTANT INFORMATION FOR REMOVING THE DETECTOR. THERE IS NO INSTALLED BASE OF THESE CRANES. THE TWO EXISTING CRANES ARE IN QUARANTINE. FIRST, THERE WILL BE PROCEDURAL UPDATES TO INCLUDE ADDITIONAL PICTURES IN THE SERVICE PROCEDURE TO PROVIDE GREATER DETAIL OF THE DETECTOR REMOVAL PROCESS. THE ADDITION OF PICTURES WILL REDUCE THE RISK INCORPORATED WITH REMOVING THE DETECTOR FROM THE GANTRY.

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6). GE HEALTHCARE'S INVESTIGATION IS ONGOING. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, WHILE SERVICING THE DEVICE, A FIELD ENGINEER BENT OVER AND WAS STRUCK ON THE TOP OF THE HEAD BY THE DETECTOR TROLLEY. HE CHECKED HIS HEAD AND DIDN'T FEEL BLOOD, SO HE KEPT WORKING. TWENTY DAYS LATER HE WAS DIAGNOSED WITH A SUBDURAL HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375011 REVOLUTION CT COMPUTED TOMOGRAPHY X-RAY SYSTEM JAK GE MEDICAL SYSTEMS, LLC CSRV05 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Other