BEUDAMED
    FDA Adverse Event Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 3013515 · Received March 20, 2013

    Report

    Report Number
    1043572-2013-00024
    Date Received
    March 20, 2013
    Date of Event
    February 18, 2013
    Report Date
    March 20, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED AT THE FACILITY TO INSPECT THE UNIT SUBJECT OF THE REPORTED EVENT. THE TECHNICIAN REMOVED THE TABLE BASE COVERS TO EXAMINE THE BASE INTERIOR AND FOUND EVIDENCE INDICATIVE OF FLUID INTRUSION IN THE TABLE BASE INTERIOR. THIS FLUID INTRUSION CAUSED AN ELECTRICAL SHORT AND CARBON BLACKENING WHERE THE FUSES ARE MOUNTED ON THE TABLE BATTERY CHARGER/POWER SUPPLY PC BOARD. THE TECHNICIAN CONDUCTED DIAGNOSTICS TO DETERMINE ALL DAMAGED COMPONENTS AND PERFORMED NECESSARY REPAIRS INCLUDING PLACING RTV SEALANT AROUND THE BASE INTERIOR TO PREVENT FUTURE FLUID INTRUSION. THE TECHNICIAN TESTED THE UNIT FOR CORRECT FUNCTION/OPERATION AND RETURNED THE TABLE TO SERVICE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THE CMAX TABLE STARTED TO EMIT SMOKE AND A SMOKE ODOR. THE HOSPITAL STAFF DISCONNECTED THE TABLE FROM THE AC POWER SUPPLY AND SUCCESSFULLY COMPLETED THE SURGERY. THERE WERE NO PROCEDURAL CANCELLATIONS OR INJURIES REPORTED WITH THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116566 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1