BEUDAMED
    FDA Adverse Event Other Summary report: N

    TOSHIBA

    MDR report key: 1652388 · Received April 1, 2010

    Report

    Report Number
    2020563-2010-00005
    Event Type
    Other
    Date Received
    April 1, 2010
    Date of Event
    March 12, 2010
    Report Date
    March 5, 2010
    Manufacturer
    TOSHIBA MEDICAL SYSTEMS CORPORATION
    Product Code
    KXJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE TOSHIBA CUSTOMER ENGINEER ALONG WITH THE BIOMED REPRESENTATIVE TESTED THE CAT-850B TABLE AND IT MET ITS SPECIFICATIONS FOR TENSION ON MAGNETIC BRAKE. THE PATIENT WAS LIFTED AND RETURNED TO THE TABLE. NO REPORT OF PATIENT INJURY. TOSHIBA IS WORKING WITH THE SITE ON A POTENTIAL SOLUTION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT FELL TO THE GROUND OWING TO THE CAT-850B CATHETERIZATION TABLE PIVOTING. (B) (6). THE PATIENT'S FALL WAS SLOW AND GRADUAL SO THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOSHIBA CATHETERIZATION TABLE KXJ TOSHIBA MEDICAL SYSTEMS CORPORATION CAT-850B

    Patients

    Seq Age Sex Outcome Treatment
    1 Other