BEUDAMED
    FDA Adverse Event Summary report: N

    3085 SURGICAL TABLE

    MDR report key: 4899420 · Received July 8, 2015

    Report

    Report Number
    1043572-2015-00064
    Date Received
    July 8, 2015
    Date of Event
    June 10, 2015
    Report Date
    July 8, 2015
    Manufacturer
    STERIS CORPORATION - MONTGOMERY
    Product Code
    FQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE SURGICAL TABLE, AND IDENTIFIED A POWER CORD WHICH WAS INCOMPATIBLE WITH THE 3085 SURGICAL TABLE. THE TECHNICIAN INSPECTED THE TABLE'S INTERNAL WIRING/ELECTRICAL SYSTEM AND COULD NOT IDENTIFY ANY ISSUES. THE TECHNICIAN REPLACED THE INCOMPATIBLE POWER CORD WITH A POWER CORD DESIGNED FOR THE 3085 SURGICAL TABLE, TESTED THE SURGICAL TABLE, AND CONFIRMED IT TO BE OPERATING ACCORDING TO SPECIFICATION. THE INCOMPATIBLE POWER CORD ALLOWED FOR A PHYSICAL GAP IN THE CONNECTION BETWEEN THE POWER CORD AND THE TABLE'S RECEPTACLE. THIS IMPROPER FITTING ALLOWED FOR FLUID TO MAKE CONTACT WITH THE ELECTRICAL CURRENT RUNNING BETWEEN THE CORD AND THE TABLE WHICH THEN SHOCKED THE EMPLOYEE. SECTION 1 OF THE OPERATOR MANUAL STATES, "WARNING - PERSONAL INJURY AND/OR EQUIPMENT DAMAGE HAZARD: REPAIRS AND ADJUSTMENTS TO THIS EQUIPMENT MUST BE MADE ONLY BY FULLY QUALIFIED SERVICE PERSONNEL. NONROUTINE MAINTENANCE PERFORMED BY INEXPERIENCED, UNQUALIFIED PERSONNEL OR INSTALLATION OF UNAUTHORIZED PARTS COULD CAUSE PERSONAL INJURY, INVALIDATE THE WARRANTY OR RESULT IN COSTLY DAMAGE." THE EMPLOYEE HAS RETURNED TO NORMAL WORK DUTIES AND THE TECHNICIAN HAS DISCUSSED THE IMPORTANCE OF USING THE APPROPRIATE POWER CORD WHEN OPERATING A 3085 SURGICAL TABLE. THE SURGICAL TABLE IS NOT UNDER STERIS CONTRACT AGREEMENT FOR MAINTENANCE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED AN EMPLOYEE RECEIVED AN ELECTRICAL SHOCK WHEN CLEANING IRRIGATION FLUID SPILLAGE AROUND THEIR 3085 SURGICAL TABLE'S AC INLET RECEPTACLE. THE EMPLOYEE SOUGHT MEDICAL TREATMENT. HOWEVER IT WAS NOT DISCLOSED WHAT TYPE OF MEDICAL TREATMENT WAS ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    443854 3085 SURGICAL TABLE SURGICAL TABLE FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1