BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2233470 · Received September 2, 2011

    Report

    Report Number
    2020563-2011-00015
    Event Type
    Injury
    Date Received
    September 2, 2011
    Date of Event
    October 8, 2010
    Report Date
    September 2, 2011
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION WAS CONDUCTED BY THE MANUFACTURER AND IT WAS DETERMINED THAT THE CAUSE OF THE INCIDENT WAS USER ERROR. INSTRUCTIONS TO AVOID THIS PROBLEM FROM HAPPENING IS DESCRIBED IN THE DEVICE'S SAFETY MANUAL.THE PATIENT'S INNER THIGHS TOUCHING CAUSED AN RF CURRENT LOOP WHICH IN TURN CAUSED A BURN. PER THE MANUFACTURER, FOAM PADS OR OTHER APPROPRIATE MATERIAL SHOULD HAVE BEEN PLACED BETWEEN THE PATIENT'S INNER THIGHS TO AVOID CONTACT.

    Additional Manufacturer Narrative · 1

    AFTER RECEIVING THE REPORT OF THIS ACCIDENT, TOSHIBA SERVICE ENGINEER PERFORMED AN INVESTIGATION OF THE ACCIDENT, THE USE HISTORY OF THE SYSTEM, THE SYSTEM ITSELF AND THE ARM UP HOLDER. TOSHIBA SERVICE ENGINEER CONFIRMED THAT THE ARM UP HOLDER HAD NO SHARP EDGE IN THE REACH OF THE PATIENT, AND THAT THERE WERE NO ABNORMALITIES IN THE SYSTEM. THE OPERATION MANUAL OF THIS SYSTEM DESCRIBES THAT "POSITION THE PATIENT ON THE COUCH TOP, THEN RAISE THE PATIENT'S ARMS AND PLACE THEM ON THE ARM UP HOLDER. AT THIS TIME, POSITION THE PATIENT ON THE COUCH TOP WITH CARE TO AVOID HITTING THE PATIENT'S HEAD OR ARMS". RESULTS: THE CAUSE OF THE ACCIDENT IS CONSIDERED TO BE; THE OPERATOR DIDN'T MOVE THE PATIENT ACCORDING TO THE OPERATION MANUAL, ADDITIONALLY, THE PATIENT MOVED BY HIMSELF AS UNEXPECTED. BECAUSE THESE EVENTS HAPPENED AT THE SAME TIME, THE PATIENT'S HEAD STRUCK THE ARM UP HOLDER WITH CONSIDERABLE FORCE. THIS REPORT IS BEING FILED AS THE RESULT OF A RETROSPECTIVE REVIEW OF COMPLAINTS DURING AN INTERNAL AUDIT.

    Description of Event or Problem · 1

    AFTER PUTTING THE PATIENT ON THE PATIENT COUCH, AS SOON AS A NURSE AND A MEDICAL TECHNICIAN STARTED MOVING THE PATIENT TOWARD THE DIRECTION OF THE HEAD FOR SCAN POSITION SETTING, THE PATIENT SUDDENLY STARTED MOVING TOWARD IN THE SAME DIRECTION. THE RESULTANT MOVEMENT WAS UNCONTROLLED AND THE PATIENT'S HEAD STRUCK THE ARM UP HOLDER ATTACHED TO THE PATIENT CRADLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1