BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 2080685 · Received May 6, 2011

    Report

    Report Number
    1043572-2011-00027
    Event Type
    Malfunction
    Date Received
    May 6, 2011
    Date of Event
    April 6, 2011
    Report Date
    May 6, 2011
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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 PLACED THE TABLE BACK INTO SERVICE. STERIS ENGINEERING EVALUATED PHOTOGRAPHS OF THE REPLACED POWER SUPPLY AND DETERMINED THAT IT WAS DAMAGED FROM FLUID INTRUSION ONTO THE POWER SUPPLY. THE CAUSE OF THIS EVENT IS FROM IMPROPER SEALING OF THE TABLE'S BASE AFTER IT WAS LAST SERVICED. THE STERIS SERVICE TECHNICIAN RECEIVED REFRESHER TRAINING ON PROPER SEALING PROCEDURES FOR THIS SURGICAL TABLE ON (B)(6) 2011.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE THE SURGICAL TABLE BASE BEGAN TO SMOKE. THE PATIENT WAS TRANSFERRED TO ANOTHER SURGICAL TABLE 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 GDC STERIS CORPORATION - MONTGOMERY CMAX

    Patients

    Seq Age Sex Outcome Treatment
    1 Other