BEUDAMED
    FDA Adverse Event Summary report: N

    3080SP SURGICAL TABLE

    MDR report key: 2870707 · Received December 12, 2012

    Report

    Report Number
    1043572-2012-00097
    Date Received
    December 12, 2012
    Date of Event
    November 13, 2012
    Report Date
    December 12, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE STERIS SERVICE TECHNICIAN INSPECTED THE TABLE AND WAS NOT ABLE TO DUPLICATE THE REPORTED ISSUE. THE TECHNICIAN IDENTIFIED DAMAGE TO THE OVERRIDE SWITCH COVER AND TABLE SHROUDS. THIS TYPE OF DAMAGE IS INDICATIVE OF STORING ITEMS ON THE BASE OF SURGICAL TABLES, WHICH IS WARNED AGAINST IN THE TABLE'S LABELING. DURING HIS INSPECTION OF THE TABLE, THE TECHNICIAN OBSERVED THE PROTECTIVE COVER OVER THE AUXILIARY SWITCHES WAS BROKEN LOOSE. ALTHOUGH THE TECHNICIAN COULD NOT DUPLICATE THE REPORTED EVENT, HE OBSERVED THAT WHEN THE TABLE WAS TILTED, THE TABLE SHROUD APPLIED PRESSURE TO THE PROTECTIVE SWITCH COVER, WHICH MAY HAVE ENGAGED THE TREND OVERRIDE SWITCH CAUSING THE FOOT OF THE BED TO DROP 90° RATHER THAN GRADUALLY ANGLING INTO REVERSE TRENDELENBURG. THE OPERATOR MANUAL FOR 3080SP SURGICAL TABLES STATES (PP 1-2): "WARNING-PERSONAL INJURY HAZARD: UNANTICIPATED TABLE MOVEMENT COULD CAUSE PATIENT INJURY. PATIENT MUST BE SECURED TO THE TABLE IN ACCORDANCE WITH RECOMMENDED POSITIONING PRACTICE." THE TABLE IS EQUIPPED WITH A CB-2 CIRCUIT BREAKER WHICH HAS AN EXTRA INTERNAL MANUAL ON/OFF SWITCH. THE PROPER PROTOCOL FOR EMERGENCY SHUT OFF IS TO ACTIVATE THE CB-2 SWITCH AND DISCONNECT THE POWER CORD, REMOVING ALL POWER FROM THE TABLE. THE TABLE IS NOT UNDER STERIS SERVICE CONTRACT AND IS SERVICED AND MAINTAINED BY A 3RD PARTY SERVICE GROUP. THIS MODEL TABLE WAS THE SUBJECT OF A 2007 OBSOLESCENCE NOTICE TO CUSTOMERS. THE USER FACILITY HAS STATED THAT THEY WILL NOT PUT THE TABLE SUBJECT OF THE REPORTED EVENT BACK IN SERVICE. THEY HAVE ORDERED THREE REPLACEMENT TABLES FOR THE FACILITY'S REMAINING 3080 TABLES. THE USER FACILITY RECEIVED FULL IN-SERVICE TRAINING ON THEIR REPLACEMENT TABLES INCLUDING PROTOCOLS ON DISCONNECTING THE TABLE'S POWER IN CASE OF AN EMERGENCY ON DECEMBER 3, 2012.

    Description of Event or Problem · 1

    DURING A PATIENT PROCEDURE WITH THE SURGERY SITE OPEN, THE PATIENT WAS ORIENTED IN THE REVERSE POSITION AND THE DOCTOR ASKED FOR REVERSE TRENDELENBURG. REPORTEDLY, RATHER THAN GRADUALLY ANGLING INTO REVERSE TRENDELENBURG, THE FOOT SECTION OF THE BED DROPPED AT A 90° ANGLE. TO STOP FURTHER MOVEMENT, PERSONNEL IN THE ROOM TRIED UNPLUGGING THE TABLE FROM THE ELECTRIC OUTLET AND TURNING OFF THE HAND CONTROL BUT WERE UNABLE TO STOP THE MOVEMENT OF THE TABLE. THE PATIENT SLID OFF OF THE TABLE AND WAS ASSISTED BY PERSONNEL ONTO MATTRESS PADS ON THE FLOOR. A TABLE FROM ANOTHER ROOM WAS BROUGHT IN AND THE PATIENT WAS TRANSFERRED TO THE NEW TABLE WHERE THE SURGERY WAS SUCCESSFULLY COMPLETED. THERE WAS NO SUSTAINING INJURY REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3080SP SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1