BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA

    MDR report key: 2568805 · Received May 10, 2012

    Report

    Report Number
    2020563-2012-00007
    Event Type
    Injury
    Date Received
    May 10, 2012
    Date of Event
    April 6, 2012
    Report Date
    April 10, 2012
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE (B)(6) AT (B)(6) HOSPITAL REPORTED TO THE TOSHIBA ENGINEER THAT THE INJURED CT TECHNOLOGIST REQUIRED STITCHES ON HER FINGER AND WAS OUT OF WORK FOR 5 DAYS. RESULT: TOSHIBA IS CURRENTLY WORKING TO DETERMINE THE EXACT PARTS OF THE COUCH THAT CAUSED THE INJURY.

    Additional Manufacturer Narrative · 1

    IT WAS DETERMINED BY THE MANUFACTURER THAT THE CAUSE OF THE PROBLEM WAS AN OPERATIONAL ERROR BY THE USER OF THE DEVICE. THE FOLLOWING ACTIONS HAVE BEEN TAKEN BY THE MANUFACTURER: IMPROVEMENTS DESIGN CHANGE FOR THE GAP FOR SYSTEMS MANUFACTURED BEGINNING IN 2009. A LETTER WAS SENT TO CUSTOMERS INFORMING THEM OF THIS INCIDENT AND TO REMIND THEM OF THE PRECAUTIONS TO OBSERVE WHEN USING THE COUCH. (THESE PRECAUTIONS ARE STATED IN THE SAFETY MANUAL).

    Description of Event or Problem · 1

    CT TECHNOLOGIST WAS SLIDING TABLE TOP TOWARD FOOT END OF COUCH. HER LEFT HAND WAS ON THE LEFT COVER OF THE UPPER COVER ASSEMBLY. COUCH TABLE TOP WAS BEING SLID BACKWARDS WITH RIGHT HAND. LEFT HAND FINGER GOT PINCHED BETWEEN UPPER COVER ASSEMBLY AND TABLE TOP.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Other