BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 2424823 · Received January 17, 2012

    Report

    Report Number
    2424823
    Event Type
    Malfunction
    Date Received
    January 17, 2012
    Date of Event
    September 2, 2011
    Report Date
    January 17, 2012
    Manufacturer
    STERIS
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA, US

    Narratives

    Description of Event or Problem · 1

    AS THE SURGERY STAFF WAS PREPPING THE SURGERY SUITE FOR THEIR NEXT PATIENT THEY NOTICED A LARGE POOL OF HYDRAULIC FLUID NEAR THE BASE OF THE OR TABLE. THE TABLE WAS REMOVED AND SENT TO BIOMED FOR DIAGNOSIS. WHEN THE BIOMED TECH OPENED THE TABLE UP THE FIRST THING HE NOTICED WAS THE HYDRAULIC LINE TO THE SEAT SECTION HAD A VISIBLE RUPTURE. ON CLOSER INSPECTION IT WAS FOUND THAT THE SET SCREWS HOLDING THE RIGHT SIDE CYLINDER BRACKET HAD BROKEN ALLOWING IT TO MOVE FREELY. IT APPEARS THAT THIS IS WHAT CAUSED THE HYDRAULIC HOSE FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * SURGICAL TABLE FQO STERIS 3085SP *

    Patients

    Seq Age Sex Outcome Treatment
    1 *