BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2714870 · Received February 3, 2012

    Report

    Report Number
    2020563-2012-00003
    Event Type
    Injury
    Date Received
    February 3, 2012
    Date of Event
    December 16, 2011
    Report Date
    January 5, 2012
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RADIOLOGIC TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE PT WAS ON THE COUCH HEAD FIRST AND SUPINE WITH ARMS DOWN BY THE SIDE AND HANDS ON CHEST. AS THE PT WAS BEING SENT INTO THE GANTRY, THE ARM WAS PINCHED BY THE MOVING COUCH TOP BETWEEN THE COUCH TOP AND COUCH. THE VINYL COVERING FOR THE COUCH TOP THAT SLIPS OVER THE COUCH TOP PAD DID NOT COVER THE GAP BETWEEN THE COUCH TOP AND THE COUCH. THERE WAS A SHEET UNDER THE PT, BUT IT WAS NOT COVERING THE ENTIRE COUCH TOP. THE PT WAS ONLY PINCHED. THERE WAS NO BREAKING OF THE SKIN OR NEED FOR MEDICAL TREATMENT.

    Description of Event or Problem · 1

    AS A PT WAS BEING SENT INTO THE GANTRY, THE PT'S ARM WAS PINCHED BY THE MOVING COUCH TOP BETWEEN THE COUCH TOP AND THE COUCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA COMPUTER TOMOGRAPHY SYSTEM JAK TOSHIBA MEDICAL SYSTEMS CORPORATION TSX-101A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other