A steris service technician arrived onsite to inspect the harmonyair e-series surgical light and confirmed that the plastic ring had detached from the lighthead.The technician observed that the plastic ring was broken which is indicative of facility personnel bumping the lighthead into other pieces of equipment.The harmonyair e-series surgical light operator manual states (4-1), "caution - possible equipment damage: do not bump lightheads into walls or other equipment.Always use handles or gripping surface when positioning lighthead during surgical procedures, or when cleaning or servicing the lighting system." the technician replaced the lighthead, tested the lighting system, confirmed it to be operating according to specification and returned it to service.A 3-year complaint review indicates this to be an isolated event.A steris account manager offered in-service training on the proper use and operation of the harmonyair e-series surgical light, including the importance of not bumping the light into other equipment; however, the user facility declined.No additional issues have been reported.
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The user facility reported that prior to the start of a patient procedure, the plastic trim ring around the led indicator light on the bottom of the harmonyair e-series surgical lighthead detached and fell, entering the sterile field.The sterile field was reestablished, and the procedure was completed successfully.No report of injury or procedure delay.
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