BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 8214572 · Received January 3, 2019

    Report

    Report Number
    1043572-2019-00001
    Event Type
    Malfunction
    Date Received
    January 3, 2019
    Date of Event
    December 4, 2018
    Report Date
    January 3, 2019
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE TABLE WAS IMMEDIATELY UNPLUGGED FOLLOWING THE REPORTED EVENT. THE 3085 SURGICAL TABLE IS NOT UNDER STERIS SERVICE AGREEMENT FOR MAINTENANCE ACTIVITIES. ALL MAINTENANCE ACTIVITIES ARE PERFORMED BY A THIRD-PARTY. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE SURGICAL TABLE AND FOUND THAT THE TABLE'S AC POWER CORD AND INLET PLATE WERE DAMAGED. 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 REPORTED FLAME. THE 3085 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 THE TABLE CAUSING CORROSION AND LOSS OF FUNCTION." THE 3085 SURGICAL TABLE WAS INSTALLED IN 2008 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.

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2019 THE TECHNICIAN COUNSELED USER FACILITY PERSONNEL 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 A SMALL FLAME WAS OBSERVED ON THE CORD OF THEIR 3085 SURGICAL TABLE AT THE END OF A PATIENT PROCEDURE. NO INJURY WAS REPORTED, THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8029 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1