BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CMAX GENERAL SURGERY TABLE

    MDR report key: 1288423 · Received January 16, 2009

    Report

    Report Number
    1043572-2009-00002
    Event Type
    Malfunction
    Date Received
    January 16, 2009
    Date of Event
    December 18, 2008
    Report Date
    January 16, 2009
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    GDC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND DUPLICATED THE SITUATION DESCRIBED BY THE CUSTOMER. WHEN THE TECHNICIAN TURNED ON THE HAND CONTROL, THE HAND CONTROL DISPLAY REPORTED INCORRECT TABLE ANGLE INFORMATION AND THAT A SENSOR HAD FAILED. THE HAND CONTROL DID NOT FUNCTION PROPERLY. THE TECHNICIAN PERFORMED THE LEVEL ADJUSTMENT PROCEDURE SPECIFIED IN THE DEVICE'S MAINTENANCE MANUAL WHICH RETURNED THE TABLE TO NORMAL FUNCTIONING. THE SERVICE TECHNICIAN REPLACED THE TABLE CONTROL BOARD, AND THE HAND CONTROL AND THE TABLE WAS RETURNED BACK TO THE CUSTOMER FOR USE.

    Additional Manufacturer Narrative · 1

    ON AUGUST 12, 2010, STERIS CORPORATION ISSUED A VOLUNTARY FIELD CORRECTION (B)(4) FOR CMAX SURGICAL TABLES. STERIS HAS LEARNED THAT CERTAIN CMAX SURGICAL TABLES MAY LOSE CALIBRATION IF THE TABLE IS OPERATED ONLY ON BATTERY POWER AND IF THE TABLE IS IN A LOW BATTERY CHARGE CONDITION. THIS COULD RESULT IN THE TABLE MOVING INTO AN UNEXPECTED TILT POSITION WHEN THE "LEVEL" BUTTON IS DEPRESSED ON THE HAND CONTROL KEYPAD. STERIS HAS RECEIVED NO REPORTS OF INJURIES ASSOCIATED WITH THIS CONDITION. A LOW BATTERY CHARGE CONDITION EXISTS WHEN NO BARS ON THE TABLE LED DISPLAY ARE ILLUMINATED. LOSS OF CALIBRATION WILL NOT OCCUR IF A TABLE IS CONNECTED TO AC POWER. AS DESCRIBED IN THE CMAX SURGICAL TABLE OPERATOR MANUAL, THE TABLE SHOULD BE CONNECTED TO AC POWER AS OFTEN AND AS LONG AS POSSIBLE; CONNECTING THE TABLE TO AC POWER AS SOON AS THE LOW BATTERY CONDITION OCCURS WILL PREVENT POSSIBLE LOSS OF CALIBRATION. THE FIELD CORRECTION WILL UPDATE THE SOFTWARE IN ALL CMAX SURGICAL TABLES THAT MAY LOSE CALIBRATION WHEN USED IN A LOW BATTERY CHARGE CONDITION WHILE ON BATTERY POWER. CUSTOMERS WERE ALSO INSTRUCTED TO FOLLOW THE DIRECTIONS IN THE OPERATOR MANUAL TO KEEP TABLE(S) CONNECTED TO AC POWER AS OFTEN AND AS LONG AS POSSIBLE.

    Description of Event or Problem · 1

    DURING A PROCEDURE, THE PATIENT WAS ON A C-MAX SURGICAL TABLE WITH THE TABLE IN THE FLEX POSITION. THE TABLE BEGAN MOVING INTO THE TRENDELENBURG POSITION EVEN THOUGH NO ONE WAS TOUCHING THE HAND CONTROL. THE HOSPITAL STAFF WAS ABLE TO BRING THE TABLE TO LEVEL POSITION USING THE AUXILIARY HAND CONTROL AND FOOT PUMP. THE PATIENT WAS TRANSFERRED TO ANOTHER TABLE AND THE PROCEDURE WAS COMPLETED. THERE WAS NO INJURY TO THE PATIENT.

    Description of Event or Problem · 1

    THE CUSTOMER CONTACTED BAXTER'S (B)(4) REGARDING A CHECK SUPPLY LINE ALARM, WHICH OCCURRED ON THE HOMECHOICE DURING LAST FILL. THE HOME PATIENT (HP) STATED A SUPPLY BAG BECAME UNSPIKE DURING TREATMENT AND HE REPSIKED THE BAG. THE BAXTER TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE SET-UP IS POTENTIALLY COMPROMISED AND ASSISTED WITH ENDING THERAPY. THE TSR ADVISED THE HP TO CALL THE CLINIC AND NOTIFY THE NURSE OF WHAT HAPPENED. (B)(4) SPOKE TO THE HP REGARDING THE REPORT OF THE SPIKE SEPARATING FROM THE BAG. THE HP THOUGHT HE MIGHT NOT HAVE PUSHED THE SPIKE INTO THE BAG ALL THE WAY. THE HP DID NOT REPORT ANY DEFECT OF THE SPIKE OR SUPPLY BAG. THE HP ENDED THERAPY, DISCARDED THE SET-UP AND CONTACTED THE NURSE. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. THE HP WAS ADVISED TO ENSURE A PROPER CONNECTION WHEN SETTING UP FOR THERAPY. THE HP IS CONTINUING THERAPY ON THE CYCLER WITH NO FURTHER ISSUES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CMAX GENERAL SURGERY TABLE TABLE, OPERATING-ROOM, ELECTRICAL GDC STERIS CORPORATION - MONTGOMERY 2182625 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention