BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3085SP SURGICAL TABLE

    MDR report key: 8075548 · Received November 15, 2018

    Report

    Report Number
    1043572-2018-00091
    Event Type
    Malfunction
    Date Received
    November 15, 2018
    Date of Event
    October 23, 2018
    Report Date
    November 15, 2018
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS ACCOUNT MANAGER OFFERED IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE 3085 SURGICAL TABLE SPECIFICALLY, PROPER CLEANING TECHNIQUES; HOWEVER, THE USER FACILITY DECLINED. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE 3085SP SURGICAL TABLE AND FOUND THAT THE TABLE'S AC POWER CORD AND INLET PLATE WERE DAMAGED. THE TECHNICIAN WAS INFORMED THAT THE TABLE STARTED TO SMOKE AND SPARK WHILE THE FACILITY'S STAFF WAS CLEANING THE OR ROOM. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THE TECHNICIAN REPLACED THE TABLE'S AC POWER CORD AND INLET PLATE, TESTED THE TABLE, CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED THE TABLE TO SERVICE. THE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO EXPOSURE TO LIQUID FROM CLEANING. THIS CAUSED AN ELECTRICAL SHORT, WHICH CAUSED THE TABLE TO SMOKE AND SPARK. THE 3085SP SURGICAL TABLE'S OPERATOR MANUAL (1-3) STATES: "CAUTION: POSSIBLE EQUIPMENT DAMAGE: DO NOT SPRAY CLEANING FLUID INTO ELECTRIC RECEPTACLES AND AVOID SPRAYING DIRECTLY ONTO OVERRIDE SWITCHES OR INTO CLEARANCE SPACE ABOVE COLUMN. SPRAY OR DRIPPAGE MAY SETTLE ONTO ELECTRIC CIRCUITS INSIDE TABLE CAUSING CORROSION AND LOSS OF FUNCTION." THE SURGICAL TABLE WAS INSTALLED IN (B)(6) 2010 AND IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. A STERIS ACCOUNT MANAGER WILL OFFER IN-SERVICE TRAINING ON THE PROPER USE AND OPERATION OF THE 3085 SURGICAL TABLE SPECIFICALLY, PROPER CLEANING TECHNIQUES. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEIR 3085SP SURGICAL TABLE STARTED SMOKING AND SPARKING FROM THE AC POWER CORD INLET. NO INJURY OR PROCEDURE DELAY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912613 3085SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1