BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIGHT SPEED QX/I TABLE ASSEMBLY

    MDR report key: 696961 · Received April 6, 2006

    Report

    Report Number
    2126677-2006-00011
    Event Type
    Injury
    Date Received
    April 6, 2006
    Date of Event
    February 9, 2006
    Report Date
    April 6, 2006
    Manufacturer
    GE MEDICAL SYSTEMS, LLC
    Product Code
    JAK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A DR WAS SOMEHOW HOLDING ONTO THE CRADLE DURING MOVEMENT OF THE PT FROM THE GANTRY. AS THE CRADLE CAME OVER THE TABLE THE DR'S FINGER GOT PINCHED BETWEEN THEM. THIS RESULTED IN A FRACTURE IN HIS FINGER AND A CUT. THE SITE REFUSED TO PROVIDE FURTHER DETAILS OR INFO. THIS IS A CASE OF MIS-OPERATION BY THE DR. THERE WAS NO PRODUCT MALFUNCTION. THE CRADLE AND TABLE WERE AND ARE OPERATING NORMALY. THE CRADLE TO TABLE GAP IS DESIGNED PER IEC FINGER PINCH POINT REQUIREMENTS. PREVIOUS CASES OF FINGER PINCH HAVE NEVER RESULTED IN SERIOUS INJURY. THE UNIQUE CIRCUMSTANCES (DR GRABBING THE CREDLE) CONTRIBUTED TO THE INJURY STENT. THE OPERATION MANUAL PROVIDES CAUTIONS ABOUT NOT HOLDING ONTO THE CRADLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIGHT SPEED QX/I TABLE ASSEMBLY CT JAK GE MEDICAL SYSTEMS, LLC 2225283 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN