BEUDAMED
    FDA Adverse Event Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 3202835 · Received July 2, 2013

    Report

    Report Number
    1043572-2013-00069
    Date Received
    July 2, 2013
    Date of Event
    June 6, 2013
    Report Date
    July 2, 2013
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN ARRIVED ONSITE AND VISUAL EXAMINATION OF THE TABLE REVEALED CONSIDERABLE AREA OF THE TABLE COLUMN COVERS AND BASE COVER EXHIBITED WETNESS MARKS OF FLUID CONTACT/POOLING. VISUAL EXAMINATION ALSO REVEALED THE TWO HALVES OF THE COLUMN CAP COVER WERE NOT SEATED TOGETHER AND EXHIBITED A GAP ~1/8 INCH SEPARATING THE TWO HALVES. THESE COVERS ALSO HAD WETNESS MARKS OF FLUID CONTACT. THE TECHNICIAN REMOVED THE TABLE BASE COVERS AND FOUND THAT ONLY ONE OF THE SOCKET HEAD SCREWS HAD A PLASTIC WASHER. THESE WASHERS ARE PRESENT TO MITIGATE THE POTENTIAL FOR FLUID INTRUSION AT THE POINT OF SCREW INSTALLATION. EXAMINATION OF THE TABLE COMPONENTS LOCATED WITHIN THE TABLE BASE REVEALED FLUID POOLED ON THE TOP OF THE TABLE POWER SUPPLY/BATTERY CHARGER. THE BATTERY CABLE CONNECTS HAD BURNED/MELTED THROUGH AND THE MANUAL FOOT PUMP PEDAL WAS BROKEN. THE TECHNICIAN WAS ADVISED THAT THE PEDAL WAS BROKEN DURING THE FACILITIES ACTIVITIES IN REMOVING THE TABLE FROM THE OR. THE USER FACILITY WILL REPAIR THE TABLE UPON RECEIPT OF THE COMPONENTS. THE TABLE WAS MANUFACTURED IN 2007 AND IS NOT UNDER STERIS SERVICE CONTRACT. THE STERIS TECHNICIAN HAS ADVISED THE USER FACILITY OF THE PROPER MAINTENANCE FOR THE TABLE, SPECIFICALLY ON HOW TO PROPERLY SEAL THE TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AFTER THE CONCLUSION OF A PATIENT PROCEDURE, THE CMAX SURGICAL TABLE BEGAN TO EMIT SMOKE FROM THE BASE. THE FIRE DEPARTMENT WAS SUMMONED AND DIRECTED THE TABLE BE REMOVED FROM THE OR. NO PATIENT WAS PRESENT IN THE ROOM DURING THE TIME OF THE REPORTED EVENT. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301178 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1