BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 5052943 · Received September 3, 2015

    Report

    Report Number
    1043572-2015-00080
    Date Received
    September 3, 2015
    Date of Event
    June 11, 2015
    Report Date
    September 3, 2015
    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 SERVICE TECHNICIAN ARRIVED AT THE USER FACILITY IN AN EFFORT TO OBTAIN ADDITIONAL INFORMATION REGARDING THE EVENT, AND INSPECT THE SURGICAL TABLE. THE TECHNICIAN WAS INFORMED THAT THE AMOUNT OF SMOKE OBSERVED WAS SMALL AND DID NOT REQUIRE TRANSFER OF THE PATIENT TO ANOTHER TABLE OR OPERATING ROOM IN THE FACILITY. THE STERIS TECHNICIAN WAS INFORMED THE TABLE'S POWER CORD AND AC PLATE ASSEMBLY WERE REPLACED FOLLOWING THE EVENT AND THE DAMAGED COMPONENTS HAD BEEN DISCARDED BY THE FACILITY. THE 3085 SURGICAL TABLE SUBJECT OF THE EVENT WAS INSTALLED IN 2005 AND IS NOT UNDER A STERIS SERVICE CONTRACT. THE USER FACILITY'S BIOMEDICAL DEPARTMENT IS RESPONSIBLE FOR ENSURING THE PROPER PREVENTIVE MAINTENANCE IS PERFORMED AT THE INTERVALS RECOMMENDED IN THE 3085 OPERATOR MANUAL TO ENSURE THE PROPER OPERATION OF THE SURGICAL TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VIA MW5043482, THAT DURING A PATIENT PROCEDURE, THE FACILITY STAFF DETECTED A BURNING SMELL AND SMOKE EMITTING FROM THE POWER OUTLET FROM WHICH THE 3085 SURGICAL TABLE WAS CONNECTED. THE SURGICAL TABLE WAS IMMEDIATELY DISCONNECTED FROM THE CIRCUIT PLUG AND THE SURGICAL TABLE WAS POWERED DOWN. THERE WAS NO INJURY TO PATIENT OR STAFF REPORTED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    585007 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1