BEUDAMED
    FDA Adverse Event Summary report: N

    4085 SURGICAL TABLE

    MDR report key: 4152680 · Received October 8, 2014

    Report

    Report Number
    1043572-2014-00101
    Date Received
    October 8, 2014
    Date of Event
    August 26, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    A SERVICE TECHNICIAN INSPECTED THE TABLE AND FOUND THAT THE FLOOR LOCK MANIFOLD REQUIRED REPLACEMENT. THE MANIFOLD WAS REPLACED AND THE TABLE WAS RETURNED TO SERVICE. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR 4085 SURGICAL TABLE MOVED DURING A PROCEDURE AFTER AN UNCOMMANDED UNLOCKING OF THE FLOOR LOCK FEET. NO REPORT OF INJURY. A PROCEDURAL DELAY WAS REPORTED AS A RESULT OF THE TABLE MOVEMENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631065 4085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1