BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TOSHIBA INFINIX TABLE PAD

    MDR report key: 1416132 · Received July 14, 2009

    Report

    Report Number
    2020563-2009-00011
    Event Type
    Injury
    Date Received
    July 14, 2009
    Date of Event
    June 9, 2009
    Report Date
    June 15, 2009
    Manufacturer
    CONTOUR FABRICATORS, INC.
    Product Code
    KXJ
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - NO EVALUATION WILL BE CONDUCTED. RESULTS - IT IS CONSIDERED THAT USER ERROR WAS THE CAUSE OF THE INCIDENT. THE CUSTOMER DID NOT FOLLOW PATIENT HANDLING METHODS OUTLINED IN THE OPERATION MANUAL. THE CUSTOMER STATED TO THE TAMS CUSTOMER ENGINEER THAT THE PAD WAS TOO SLIPPERY ON THE TABLE TOP. IT WAS STATED TO THE CUSTOMER THAT THIS IS A STANDARD PAD AND NONE ARE MADE ANY LESS SLIPPERY. THE TABLE PAD WAS ORDERED BY THE CUSTOMER AS AN ADDITIONAL PAD TO THE PAD THAT IS INCLUDED WITH THE SYSTEM. IT WAS SUBSEQUENTLY REPORTED TO TAMS BY THE HOSPITAL THAT THE PATIENT DIED SOMETIME FOLLOWING THE INCIDENT. THE CAUSE OF DEATH WAS NOT RELATED TO THE INCIDENT.

    Description of Event or Problem · 1

    A PATIENT WAS PLACED ON A PAD ON TOP OF THE CATHETERIZATION TABLE (TOSHIBA MODEL CAT-850B) AND WAS PREPPED FOR A STUDY. THE PATIENT HAD AN ARM SUPPORT PLACED UNDER HER RIGHT ARM, BUT NOT THE LEFT BECAUSE THE PATIENT WAS ATTACHED TO A VENTILATOR. THE TABLE TOP WAS EXTENDED TOWARD THE C-ARM OF THE TOSHIBA INFINIX X-RAY SYSTEM. THE PATIENT HAD A VELCRO STRAP ACROSS LOWER BODY, BUT NOT UPPER BODY. A TECHNICIAN WAS ON THE RIGHT SIDE OF THE PATIENT. THE PATIENT STARTED MOVING AND HER UPPER BODY, INCLUDING PAD SLIPPED OFF THE LEFT SIDE OF THE TABLE, AND THE PATIENT'S HEAD STRUCK THE LOWER BASE OF THE C-ARM. THE PATIENT'S LOWER BODY STAYED UP ON THE TABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA INFINIX TABLE PAD SURGICAL TABLE CUSHION KXJ CONTOUR FABRICATORS, INC. 350B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other