BEUDAMED
    FDA Adverse Event Summary report: N

    CMAX SURGICAL TABLE

    MDR report key: 3800428 · Received May 8, 2014

    Report

    Report Number
    1043572-2014-00042
    Date Received
    May 8, 2014
    Date of Event
    March 11, 2014
    Report Date
    May 8, 2014
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORTED EVENT OCCURRED WITH THE TABLE TOP SLID TOWARDS THE FOOT END OF THE TABLE WITH THE PATIENT'S LEGS POSITIONED IN LEG STIRRUPS. THE FACILITY WAS UNABLE TO CONFIRM IF THE STIRRUPS IN USE AT THE TIME OF THE EVENT WERE OF STERIS MANUFACTURE. THE PATIENT'S WEIGHT WAS REPORTED TO BE APPROXIMATELY (B)(6). A STERIS SERVICE SPECIALIST ARRIVED AT THE FACILITY, INSPECTED THE CMAX TABLE AND CONFIRMED THE TABLE PERFORMED NORMALLY AND CORRECTLY TO ALL TABLE FUNCTIONS AND OPERATIONS. THE SERVICE SPECIALIST NOTED THE FLOOR LOCK CYLINDER LOCATED ON THE LEFT HEAD END EXHIBITED LEAKAGE OF HYDRAULIC FLUID. THE TECHNICIAN PROVIDED THE CUSTOMER WITH THE PART NUMBER REQUIRED TO REPAIR THE FLOOR LOCK CYLINDER. THE TABLE WAS INSTALLED IN 2007 AND IS NOT UNDER STERIS SERVICE CONTRACT. THE TABLE IS MAINTAINED BY A THIRD PARTY SERVICE PROVIDER, GE BIOMED. THE FACILITY STATED THEY DO NOT BELIEVE THE CMAX TABLE FAILED TO PERFORM CORRECTLY OR CONTRIBUTED TO THE PATIENT SLIDING IN THE REPORTED EVENT. THE CMAX OPERATOR MANUAL (1-2) CONTAINS THE FOLLOWING WARNINGS, "WARNING - PERSONAL INJURY HAZARD: FAILURE TO KEEP THE PATIENT PROPERLY SECURED WITH THE PATIENT SAFETY STRAPS AT ALL TIMES COULD RESULT IN DEATH OR SERIOUS INJURY TO THE PATIENT AND THE OPERATING ROOM STAFF." IN ADDITION, "UNANTICIPATED TABLE MOVEMENT COULD CAUSE PATIENT INJURY. PATIENT MUST BE SECURED TO THE TABLE IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICES." A STERIS ACCOUNT MANAGER WILL OFFER THE FACILITY A FULL IN-SERVICE ON THE PROPER USE AND OPERATION OF THE CMAX SURGICAL TABLE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, A PATIENT ALMOST SLID OFF OF THE CMAX TABLE. THE FACILITY REQUESTED A STERIS SERVICE TECHNICIAN INSPECT THE CMAX TABLE TO ENSURE IT IS OPERATING TO SPECIFICATION. NO INJURIES OR PROCEDURAL DELAYS/CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277557 CMAX SURGICAL TABLE SURGICAL TABLE GDC STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1 Other