BEUDAMED
    FDA Adverse Event Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 3023838 · Received March 27, 2013

    Report

    Report Number
    1043572-2013-00030
    Date Received
    March 27, 2013
    Date of Event
    February 25, 2013
    Report Date
    March 27, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED VIA MEDWATCH THAT A CMAX SURGICAL TABLE EMITTED SMOKE AND A BURNING SMELL IMMEDIATELY FOLLOWING A "WET CASE" PATIENT PROCEDURE (LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY). THE USER FACILITY STATED THAT THE PATIENT WAS NOT INJURED; THE PROCEDURE HAD BEEN COMPLETED AND THE PATIENT HAD BEEN REMOVED FROM THE ROOM PRIOR TO THE INCIDENT. NO PROCEDURAL DELAYS OR CANCELLATIONS WERE REPORTED. THE USER FACILITY REPORTED THAT NO FLAMES WERE OBSERVED. THE USER FACILITY STATED THAT THE PATIENT AND TABLE WERE PROPERLY DRAPED. THE TABLE WAS UNPLUGGED AND MOVED TO AN EMPTY OR ROOM. SEVERAL HOURS LATER, THE SMOKE AND BURNING SMELL PERSISTED DUE TO BATTERY POWER TO THE TABLE. THE FIRE DEPARTMENT WAS PRESENT AT THE FACILITY FOR AN UNRELATED ISSUE. THE FIRE DEPARTMENT PERSONNEL WERE SUMMONED TO THE AREA, AND USED A FIRE EXTINGUISHER ON THE TABLE. A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT, AND FOUND THAT A FUSE LOCATED ON THE SIDE OF THE BASE BY THE HYDRAULIC PUMP HAD BURNED AND MELTED THE SIDE OF THE RESERVOIR. THE TB2 PLUG ON THE POWER SUPPLY WAS BURNED, AS WERE CABLES FROM TB6 AND TB4. SEVERAL HYDRAULIC LINES WERE MELTED. ON THE BOTTOM OF THE SHROUD, THERE WAS FOAM RUBBER TAPE APPLIED TO THE BOTTOM BASE OF THE TELESCOPING SHROUD TO PREVENT FLUID INTRUSION. THE FOAM TAPE HAD NO SILICONE ON IT. VIRTUALLY NO RTV SEALANT REMAINED. THE CUSTOMER AND SERVICE TECHNICIAN BELIEVE THE TABLE IS NOT REPARABLE. THE TABLE WAS REMOVED FROM SERVICE. THE UNIT WAS INSTALLED ON (B)(6) 2009, AND IS NOT UNDER STERIS SERVICE CONTRACT. THE TABLE WAS MAINTAINED BY FACILITY BIOMED. THE TECHNICIAN PROVIDED THE USER FACILITY WITH A COPY OF THE EXCERPT OF THE MAINTENANCE MANUAL WHICH PROVIDES INSTRUCTION ON PROPERLY SEALING THE TABLE WITH RTV, AND STRESSED THE IMPORTANCE OF PROPERLY SEALING THE BASE COVERS AFTER ANY MAINTENANCE ACTIVITY THAT REQUIRES REMOVAL OF THE COVERS.

    Description of Event or Problem · 1

    SEE USER FACILITY MEDWATCH (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127182 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1