BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 5780734 · Received July 9, 2016

    Report

    Report Number
    2020563-2016-00004
    Event Type
    Injury
    Date Received
    July 9, 2016
    Date of Event
    June 2, 2016
    Report Date
    June 8, 2016
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    JAA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED BY THE CUSTOMER THAT A TECHNICIAN'S RIGHT HAND WAS PINNED BETWEEN THE LATERAL CAMERA FLAT PANEL DETECTOR AND THE ARM THAT SUPPORTS IT. IT ALLEGEDLY OCCURRED AS THE TECHNICIAN WAS PLACING A PROTECTIVE STERILE BAG OVER THE DETECTOR AT THE BEGINNING OF A PROCEDURE. THE CUSTOMER STATED THAT IT APPEARED THAT THE PRESSURE OF THE BAG ITSELF ACTIVATED THE SAFETY FEATURE THAT MOVES THE LATERAL CAMERA AWAY FROM THE PATIENT. THE SYSTEM (LATERAL CAMERA) PERFORMED AS INTENDED AS FAR AS MOVING BACKWARDS TO PROTECT THE PATIENT FROM IMPACT, BUT THE TECHNICIAN'S RIGHT HAND WAS BEHIND IT AT THE TIME. THE CUSTOMER ALSO STATED THAT THE TECHNICIAN'S HAND WAS PINNED FOR APPROXIMATELY 5 TO 7 SECONDS WHILE SHE WAS SEARCHING FOR THE BUTTON TO MOVE THE CAMERA AWAY. THERE WERE NO FRACTURES TO THE TECHNICIAN'S HAND, JUST A LITTLE SWELLING AROUND THE WRIST AREA AND A SMALL ABRASION FROM PULLING HER HAND OUT. THE MANUFACTURER HAS INVESTIGATED THE INCIDENT AND HAS DETERMINED THE CAUSE IS USER ERROR. THE OPERATION MANUAL CONTAINS A WARNING ABOUT GETTING HANDS CAUGHT AS FOLLOWS: "BE CAREFUL TO PREVENT HANDS FROM BEING CAUGHT IN MOVING SECTIONS OF THE SUPPORT UNIT OR CATHETERIZATION TABLE. IN PARTICULAR, SPECIAL CARE MUST BE TAKEN TO ENSURE THAT HANDS ARE NOT CAUGHT BETWEEN THE FPD AND THE FPD SUPPORT SECTION COVER OR BETWEEN THE C-ARM AND THE C-ARM SUPPORT SECTION.".

    Description of Event or Problem · 1

    A TECHNICIAN'S RIGHT HAND WAS PINNED BETWEEN LATERAL CAMERA FLAT PANEL DETECTOR AND THE ARM THAT SUPPORTS IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434981 TOSHIBA FLUOROSCOPIC X-RAY SYSTEM JAA TOSHIBA MEDICAL SYSTEMS CORPORATION INFINIX CF-I/BP

    Patients

    Seq Age Sex Outcome Treatment
    1 Other