BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 5293352 · Received December 14, 2015

    Report

    Report Number
    1043572-2015-00129
    Date Received
    December 14, 2015
    Date of Event
    November 13, 2015
    Report Date
    December 14, 2015
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE SURGICAL TABLE SUBJECT OF THE REPORTED EVENT HAS BEEN IN USE AT THE CUSTOMER'S FACILITY SINCE (B)(6) OF 2004. THE UNIT IS NOT UNDER A STERIS SERVICE CONTRACT AND IS NORMALLY MAINTAINED BY THE FACILITY'S BIOMEDICAL DEPARTMENT. A REVIEW OF STERIS SERVICE RECORDS REVEALED THAT STERIS HAS NOT SERVICED THE TABLE SINCE (B)(6) OF 2010. A STERIS SERVICE TECHNICIAN ARRIVED AT THE USER FACILITY, INSPECTED THE SURGICAL TABLE AND DETERMINED THE ROOT CAUSE OF THE REPORTED ISSUE WAS A LACK OF PROPER TABLE MAINTENANCE. THE TECHNICIAN IDENTIFIED THE TABLE HAD LOW HYDRAULIC FLUID LEVELS, WORN RUBBER TABLE CYLINDERS AND WORN TABLE FEET. THE TECHNICIAN REPLACED TWO OF THE TABLE'S FEET AND CYLINDERS AND FILLED THE HYDRAULIC RESERVOIR TO THE APPROPRIATE QUANTITY. THE TABLE WAS TESTED FOR PROPER OPERATION AND RETURNED TO THE FACILITY STAFF FOR USE. THE OPERATOR MANUAL SUPPLIED WITH EVERY 3085 TABLE INSTRUCTS THE USER TO CHECK THE HYDRAULIC OIL LEVEL, FLOOR LOCK SYSTEM, AND VERIFY THE PRESENCE OF ALL FOOT PADS AT A MINIMUM OF 6 TIMES PER YEAR. THE OPERATOR MANUAL STATES, "6.1 PREVENTIVE MAINTENANCE SCHEDULE - MAINTENANCE PROCEDURE DESCRIBED IN SECTIONS 6 AND 8 SHOULD BE PERFORMED REGULARLY AT THE INTERVALS INDICATED, USING THE MAINTENANCE SCHEDULE IN TABLE 6-1 AS A GUIDE. INCREASED USAGE OF THE TABLE MAY RESULT IN MORE FREQUENT MAINTENANCE THAN INDICATED." THE STERIS TECHNICIAN DISCUSSED THE IMPORTANCE OF PROPER TABLE MAINTENANCE WITH THE FACILITY WHILE ONSITE. NO FURTHER ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THE SURGICAL TABLE WAS NOT LOCKED DURING A SURGICAL PROCEDURE ALTHOUGH THE HAND CONTROL INDICATED A LOCKED TABLE STATUS. THE SURGICAL STAFF USED THE TABLE'S FOOT PUMP, AND TABLE OVERRIDE SWITCH TO SUCCESSFULLY LOCK THE TABLE. NO INJURY TO PATIENT OR STAFF WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    824145 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1