BEUDAMED
    FDA Adverse Event Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 3202838 · Received July 2, 2013

    Report

    Report Number
    1043572-2013-00068
    Date Received
    July 2, 2013
    Date of Event
    June 4, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THIS EVENT IS CURRENTLY IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THE CONTROL BOARD WAS DAMAGED AND NOT PROPERLY POSITIONED IN THE MOUNTING BRACKET. THE TECHNICIAN ALSO NOTED MULTIPLE SCRATCHES ON THE TABLE BASE INDICATING ITEMS BEING MOVED ACROSS THE SURFACE; NO SHROUD DAMAGE WAS NOTED.THE TECHNICIAN REPLACED THE CONTROL BOARD AND RETURNED THE TABLE TO SERVICE. NO ADDITIONAL ISSUES REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHILE CHANGING A PATIENT¿S POSITION DURING A HAND SURGERY THE SURGEON NOTED THAT THE TABLE MOVED. THE ANESTHESIOLOGIST RE-LOCKED THE TABLE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301233 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1