BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNA HDXT 1.5T

    MDR report key: 1334526 · Received March 4, 2009

    Report

    Report Number
    2183553-2009-00013
    Event Type
    Injury
    Date Received
    March 4, 2009
    Date of Event
    January 12, 2009
    Report Date
    January 12, 2009
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    LNH
    PMA / PMN Number
    K052293
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A GEHC FIELD ENGINEER EVALUATED THE TABLE, AND FOUND A BROKEN PIN. THE TABLE HAS BEEN REPLACED AT THE SITE.

    Description of Event or Problem · 1

    A TECHNOLOGIST REPORTEDLY INJURED HER WRIST AND SHOULDER WHEN SHE WAS PUSHING THE TABLE TO MOVE THE PATIENT INTO THE BORE. AFTER LANDMARKING THE PATIENT AND HITTING THE ADVANCE TO SCAN BUTTON, THE TABLE STOPPED ABRUPTLY AFTER MOVING ONLY APPROX. 6-8 INCHES. THE TECHNOLOGIST MOVED THE TABLE BACK OUT, AND TRIED TO ADVANCE THE TABLE AGAIN. SHE TRIED PUSHING ON THE TABLE TO HELP MOVE IT INTO THE BORE WHEN SHE HEARD A "POP" IN HER RIGHT WRIST AND BOTH SHOULDERS. THE PATIENT HAD X-RAYS AND MRIS DONE, AND IT WAS REPORTED THAT SHE HAD RUPTURED HER SCAPHOID LUNATE LIGAMENT AND THAT HER LUNATE BONE HAS ROTATED 90 DEGREES. THIS INJURY WILL REQUIRE SURGERY TO REPOSITION THE LUNATE BONE AND REPAIR THE RUPTURED TENDON. IN ADDITION, AN MRI REVEALED THAT SHE HAS A PARTIAL TEAR OF HER ROTATOR CUFF OF HER RIGHT SHOULDER. THIS INJURY IS CURRENTLY BEING TREATED WITH A TENS UNIT AND PHYSICAL THERAPY. SHE IS ALSO FEELING GRINDING AND POPPING IN HER LEFT SHOULDER BUT THERE HAS BEEN NO DIAGNOSED INJURY AS OF YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNA HDXT 1.5T LNH GE MEDICAL SYSTEMS, LLC 2395001-3 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention