BEUDAMED
    FDA Adverse Event Other Summary report: N

    1043572-2007-00015

    MDR report key: 977472 · Received February 22, 2007

    Report

    Report Number
    1043572-2007-00015
    Event Type
    Other
    Date Received
    February 22, 2007
    Product Code
    FQO
    Report Source
    Manufacturer report

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT CONCERNS A 15-YEAR OLD SURGICAL TABLE. HOSPITAL STAFF REPORTED THAT DURING A PROCEDURE, A DR REQUESTED THAT THE TABLE BE PLACED IN A TRENDELENBURG POSITION. THE BACK AND SEAT SECTIONS OF THE TABLE PURPORTEDLY CONTINUED TO DRIFT DOWNWARD, AFTER THE TABLE HAD BEEN SHIFTED INTO THE TRENDELENBURG POSITION. THERE WAS NO REPORT OF A PT INJURY. UPON LEARNING OF THE INCIDENT, STERIS DISPATCHED A SERVICE TECHNICIAN TO THE HOSP. THE TECHNICIAN INSPECTED THE TABLE AND FOUND NO PROBLEMS WITH IT. THE HOSPITAL'S DESCRIPTION OF THE EVENT, HOWEVER, LED THE TECHNICIAN TO BELIEVE THAT THE DOWNWARD DRIFT COULD HAVE BEEN CAUSED BY AN OBSTRUCTION IN THE HYDRAULIC SYSTEM. AS A PREVENTATIVE MEASURE, THE TECHNICAN REPLACED ALL OF THE HYDRAULIC CHECK VALVES ON THE TABLE. THE TECHNICIAN THEN TESTED THE TABLE, WHICH PASSED ALL PERFORMANCE TESTS. THE TABLE WAS RETURNED TO THE CUSTOMER UPON SUCCESSFUL COMPLETION OF THE PERFORMANCE TESTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FQO

    Patients

    Seq Age Sex Outcome Treatment
    1