BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HARMONYAIR

    MDR report key: 21653057 · Received March 20, 2025

    Report

    Report Number
    1043572-2025-00030
    Event Type
    Malfunction
    Date Received
    March 20, 2025
    Date of Event
    February 24, 2025
    Report Date
    March 20, 2025
    Manufacturer
    STERIS CORPORATION
    Product Code
    FSY
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THE PROCEDURE WAS OF APPROXIMATELY 30 MINUTES IN DURATION, AND TWO LIGHT HEADS WERE USED. THERE WAS NO INJURY, NO MEDICAL TREATMENT ADMINISTERED, NOR ANY DELAY OR CANCELLATION OF PROCEDURE REPORTED IN ASSOCIATION WITH THIS CONCERN. STERIS UNDERSTANDS THE USER FACILITY IS REVIEWING ALL THEIR PRE-PROCEDURAL STANDARD OPERATING PROCEDURES, INCLUDING THEIR TECHNIQUES FOR SKIN PREPARATION. THE USER FACILITY CONTACTED STERIS ASKING WE PERFORM AN EVALUATION OF THE LIGHTS IN AN ATTEMPT TO RULE OUT THE LIGHTS AS THE ROOT CAUSE OF THE REPORTED SKIN DISCOLORATION. A STERIS SERVICE TECHNICIAN ARRIVED ONSITE FOLLOWING THE REPORTED EVENT TO INSPECT THE LIGHTS. THE TECHNICIAN TESTED THE CONTROL AND OPERATION OF THE LIGHTS; HE ALSO TESTED THE INTENSITY LEVELS (POWER OUTPUTS) OF THE LIGHTS; NO ISSUES WERE IDENTIFIED, AND NO REPAIRS WERE MADE. THE LIGHTS WERE CONFIRMED TO BE OPERATING ACCORDING TO SPECIFICATION AND RETURNED TO SERVICE. THE HARMONY AIR G-SERIES SURGICAL LIGHTING SYSTEM OPERATOR MANUAL STATES THE FOLLOWING: "THE FOLLOWING IS AN IMPORTANT MESSAGE FROM STERIS ABOUT THE ADVANTAGES AND LIMITATIONS ASSOCIATED WITH THE USE OF HIGH INTENSITY SURGICAL LIGHTING SYSTEMS. BECAUSE OF THE VARIETY OF SURGICAL PROCEDURES PERFORMED AND THE WIDE RANGE OF INDIVIDUAL PREFERENCES OF SURGICAL STAFFS, IT IS DESIRABLE THAT A SURGICAL LIGHTING SYSTEM BE CAPABLE OF SELECTIVE CONTROL ACROSS A WIDE RANGE OF ILLUMINATION INTENSITIES. THE ILLUMINATING ENGINEERING SOCIETY (IES) STRESSES THAT IN ADDITION TO PROVIDING CONTROL OF INTENSITY, SURGICAL LIGHTING SYSTEMS SHOULD PROVIDE SHADOW CONTROL, CORRECT COLOR RENDITION, AND A SUITABLE DEPTH OF FIELD TO PROVIDE SHARP, CONSISTENT LIGHTING INTO DEEP BODY CAVITIES. AS ILLUMINATION LEVELS INCREASE, HOWEVER, RADIANT HEAT ALSO INCREASES. THEREFORE, THE IES CAUTIONS THAT FOR MOST OPERATIONS, RADIANT HEAT SHOULD BE KEPT TO A MINIMUM. THE USER OF SURGICAL LIGHTS SHOULD UTILIZE THE LOWEST POSSIBLE ILLUMINATION LEVEL SUITABLE FOR THE PROCEDURE, ESPECIALLY IN CERTAIN NEUROLOGICAL OR INTESTINAL PROCEDURES ON DELICATE, THIN, DRY OR ABNORMAL TISSUE. FURTHERMORE, FOR THE PROTECTION OF SURGICALLY EXPOSED TISSUES AND FOR THE COMFORT AND EFFICIENCY OF THE SURGEON AND ASSISTANTS, RADIANT ENERGY CAN BE EFFECTIVELY CONTROLLED BY LIMITING THE TIME OF EXPOSURE AT HIGHER ILLUMINATION LEVELS. EXTRA CARE MUST BE TAKEN WHEN THE LIGHT FIELDS FROM MULTIPLE LIGHT HEADS ARE OVERLAPPED ON THE SURGICAL SITE, SINCE THIS CONDITION CREATES A RISK OF TOO MUCH HEAT. AN INTERNATIONAL STANDARD FOR THE SAFETY OF SURGICAL LIGHTS ESTABLISHED BY THE INTERNATIONAL ELECTROTECHNICAL COMMISSION (IEC) SETS MINIMUM AND MAXIMUM LEVELS OF ILLUMINATION AND MAXIMUM LEVELS OF RADIANT HEAT THAT CAN BE EMITTED FROM A SINGLE SURGICAL LUMINAIRE. THE HARMONY AIR SURGICAL LIGHTING SYSTEM G SERIES HAS BEEN DESIGNED TO COMPLY WITH THIS INTERNATIONAL STANDARD AND TO PROVIDE A WIDE RANGE OF ILLUMINATION LEVELS WHILE MINIMIZING THE POTENTIALLY DAMAGING INFRARED HEAT IN THE SURGICAL FIELD. THE ILLUMINATION LEVEL OF SURGICAL LIGHTS CAN BE ADJUSTED THROUGH SEVERAL INTENSITY SETTINGS VIA CONVENIENTLY LOCATED CONTROLS ON EITHER THE WALL MOUNTED CONTROL CENTER OR THE LIGHT HEAD HANDLE. THE ILLUMINATION LEVEL ALSO DECREASES AS THE PATTERN SIZE INCREASES. MAXIMUM ILLUMINANCE CAN REACH 160 KLX FOR THE SMALLEST PATTERN SIZE OF THE LIGHT HEAD AND CAN BE ADJUSTED BY INTENSITY CONTROL OR PATTERN SIZE CONTROL THROUGHOUT THE ENTIRE RANGE SPECIFIED BY THE IEC." A 2-YEAR COMPLAINT REVIEW CONFIRMED THIS TO BE AN ISOLATED EVENT. NO ADDITIONAL ISSUES HAVE BEEN REPORTED. UDI RELATED DATA CLARIFICATION - THE DEVICE SUBJECT OF THE EVENT WAS MANUFACTURED PRIOR TO UDI COMPLIANCE, THEREFORE, UDI IS NOT APPLICABLE AND WAS NOT INCLUDED IN THE MDR.

    Description of Event or Problem · 0

    THE USER FACILITY CONTACTED STERIS REQUESTING FUNCTIONAL TESTING OF THEIR HARMONY AIR G-SERIES SURGICAL LIGHTS AFTER A PATIENT WAS REPORTED TO HAVE SKIN DISCOLORATION FOLLOWING COMPLETION OF A PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1373121 HARMONYAIR G-SERIES SURGICAL LIGHTING SYSTEM FSY STERIS CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown