BEUDAMED
    FDA Adverse Event Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 2193361 · Received August 5, 2011

    Report

    Report Number
    1043572-2011-00037
    Date Received
    August 5, 2011
    Date of Event
    July 8, 2011
    Report Date
    August 5, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE SURGICAL TABLE AND FOUND THAT THE POWER SUPPLY WAS DAMAGED. THE TECHNICIAN REPLACED THE POWER SUPPLY, TESTED ALL TABLE FUNCTIONS, AND SUCCESSFULLY RETURNED THE TABLE BACK TO SERVICE. IT IS CONCLUDED THAT THE CAUSE OF THIS EVENT WAS DUE TO LACK OF SEALANT BETWEEN THE STEEL AND PLASTIC BASE COVERS WHICH ALLOWED FLUID TO INGRESS INTO THE TABLE INTERIOR AND SHORT OUT THE POWER SUPPLY. THIS OCCURRED DURING THE MOST RECENT SERVICE REPAIR. THE TECHNICIAN HAS RECEIVED REFRESHER TRAINING ON THE PROPER PROCEDURE FOR RESEALING THE TABLE BASE COVERS AFTER REPAIR.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE THE SURGICAL TABLE BASE BEGAN TO SMOKE. THE TABLE WAS UNPLUGGED, THE SMOKING STOPPED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT FURTHER INCIDENT. NO INJURIES WERE REPORTED TO HOSPITAL STAFF OR PATIENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1