BEUDAMED
    FDA Adverse Event Summary report: N

    4085 GENERAL SURGICAL TABLE

    MDR report key: 4122268 · Received September 26, 2014

    Report

    Report Number
    1043572-2014-00098
    Date Received
    September 26, 2014
    Date of Event
    September 5, 2014
    Report Date
    September 26, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN INSPECTED THE TABLE AND IDENTIFIED A HYDRAULIC LEAK INTERNAL TO THE FLOOR LOCK MANIFOLD. LOSS OF PRESSURE CAUSED THE TABLE LOCK FLOOR FEET TO UNLOCK AND RETRACT UNDER THE WEIGHT OF THE TABLE. THE STERIS FIELD SERVICE TECHNICIAN REPLACED THE FLOOR LOCK MANIFOLD AND THE TABLE WAS RETURNED TO SERVICE OPERATING ACCORDING TO SPECIFICATIONS. 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 INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600571 4085 GENERAL SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1