BEUDAMED
    FDA Adverse Event Summary report: N

    HARMONY DUAL LA500 SURGICAL LIGHT

    MDR report key: 4232440 · Received November 6, 2014

    Report

    Report Number
    1043572-2014-00116
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    November 6, 2014
    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

    HARMONY LA 500 ARE EQUIPPED WITH TWO LAMPS. LAMP A, CALLED THE PRIMARY, IS ALWAYS POSITIONED AT A POINT IN THE OPTIC ASSEMBLY TO PROVIDE BEST FOCUS AND ILLUMINATION. WHEN LAMP A (PRIMARY) FAILS, LAMP B (BACKUP) ILLUMINATES IMMEDIATELY. WHEN THE SYSTEM SWITCHES FROM LAMP A TO LAMP B, TRANSMISSION OF LIGHT TO THE OPERATING TABLE IS INTERRUPTED FOR LESS THAN ONE SECOND. A STERIS FIELD SERVICE TECHNICIAN ARRIVED ONSITE, INSPECTED THE SYSTEM, AND IDENTIFIED BOTH THE PRIMARY AND SECONDARY LIGHTHEADS WERE OUT. THE TECHNICIAN REPLACED BOTH THE PRIMARY AND THE BACKUP LIGHT, TESTED, AND RETURNED THE UNIT TO SERVICE. THE TECHNICIAN ALSO PROVIDED AVAILABLE HOSPITAL PERSONNEL WITH INSTRUCTIONS AND DEMONSTRATION OF THE PROPER METHOD FOR LAMP REPLACEMENT. THE USER FACILITY HAD NOT NOTICED THE BLINKING INDICATOR ON THE LIGHTHEAD BASE WHICH NOTIFIED THE HOSPITAL STAFF OF THE PRIMARY LIGHT BURNING OUT AND THE SYSTEM FUNCTIONING ON THE BACKUP LIGHT. SECTION 6.8 OF THE OPERATOR MANUAL STATES, "THE HARMONY LA CONTROL CENTER PROVIDES A DEEPSITE LAMP-LIFE INDICATOR DISPLAY. WHEN THE CONTROL CENTER INDICATES THE LAMP HAS REACHED THE END OF ITS USABLE LIFE, CHANGE THE LAMP IMMEDIATELY." IN ADDITION, SECTION 6.6 LAMP REPLACEMENT HARMONY LA 500 LIGHTHEADS STATES, "DO NOT ALLOW A LIGHTHEAD TO OPERATE FOR ANY LENGTH OF TIME WITH ONLY ONE FUNCTIONAL LAMP. ALWAYS REPLACE A LAMP AT THE EARLIEST OPPORTUNITY."

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT DURING A PROCEDURE THEIR SURGICAL LIGHT WAS NOT POWERING ON. NO INJURIES OR PROCEDURAL DELAYS AND CANCELLATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714154 HARMONY DUAL LA500 SURGICAL LIGHT SURGICAL LIGHT FQO STERIS CORPORATION - MONTGOMERY

    Patients

    Seq Age Sex Outcome Treatment
    1