BEUDAMED
    FDA Adverse Event Summary report: N

    EQUIPMENT MANAGEMENT SYSTEM

    MDR report key: 2880254 · Received December 19, 2012

    Report

    Report Number
    1043572-2012-00101
    Date Received
    December 19, 2012
    Date of Event
    December 4, 2012
    Report Date
    December 19, 2012
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS SERVICE TECHNICIAN INSPECTED THE UNIT AND FOUND THE PANEL TAPED TO THE UNIT. THE PANEL WAS TAPED TO THE UNIT AFTER THE REPORTED EVENT OCCURRED. THE TECHNICIAN PROPERLY REATTACHED THE PANEL. UPON INSPECTION, THE TECHNICIAN FOUND THAT THE LOWER BRAKE RELEASE SWITCH WAS WORKING INTERMITTENTLY. A NEW LOWER BRAKE RELEASE SWITCH WAS INSTALLED AND BOTH UPPER AND LOWER BRAKES WERE TESTED AND VERIFIED TO BE OPERATIONAL. THE CUSTOMER HAD PREVIOUS SERVICE CALLS RELATED TO THE BRAKES ON THIS UNIT WHERE THE BRAKE BLADDER WAS 'BLOWN'. UPON HIS INSPECTION OF THE UNIT, THE TECHNICIAN FOUND DAMAGE TO THE LOWER BRAKE RELEASE SWITCH. DAMAGE TO THE LOWER BRAKE RELEASE SWITCH CAN OCCUR IF THE FACILITY IS INCORRECTLY REPOSITIONING THE UNIT WITHOUT DISENGAGING THE PNEUMATIC BRAKE. THIS MAY HAVE RESULTED IN THE SWITCH PERFORMING INTERMITTENTLY. THE OPERATOR MANUAL STATES (PP 3-5): THE CS DF80 SYSTEM HAS A PNEUMATIC BRAKE. THIS BRAKE IS CONSTANTLY ENGAGED. NEVER REPOSITION THE UNIT WITHOUT DISENGAGING THE BRAKE FIRST. PRESS THE BRAKE BUTTON TO DISENGAGE THE BRAKE. CAUTION: AVOID DAMAGE TO PNEUMATIC BRAKES. RELEASE BRAKE BUTTONS ONLY AFTER SYSTEM HAS COME TO A COMPLETE STANDSTILL". A STERIS ACCOUNT MANAGER WILL CONTACT THE FACILITY TO OFFER AN IN-SERVICE ON HOW TO CORRECTLY MANEUVER THE UNIT AS WELL AS THE IMPORTANCE OF ENGAGING AND PROPERLY DISENGAGING THE PNEUMATIC BRAKES.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE FELL WHILE OPERATING AN EQUIPMENT MANAGEMENT SYSTEM (EMS). THE CUSTOMER REPORTED THE EMS WAS DIFFICULT TO MANEUVER, SO THE EMPLOYEE PULLED THE BRAKE HANDLE LOCATED ON THE PANEL WITH FULL FORCE, CAUSING THE PANEL TO COME OFF AND THE EMPLOYEE AND PANEL TO FALL TO THE FLOOR. THE EMPLOYEE REPORTED PAIN IN THE RIGHT BUTTOCK. THE EMPLOYEE WAS GIVEN A PAIN KILLER AFTER THE EVENT AND WENT HOME. THE EMPLOYEE IS NOW BACK TO WORK AND AT PRESENT DOES NOT SHOW ANY INDICATION OF LASTING EFFECTS FROM THE EVENT. THE CUSTOMER DECLINED TO PROVIDE FURTHER DETAILS ON TREATMENT CITING HIPAA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EQUIPMENT MANAGEMENT SYSTEM EQUIPMENT MANAGEMENT SYSTEM FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1