MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; LIGHTING SYSTEM

Model Number	G-SERIES LIGHTING SYSTEM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported half of the yoke cover to their harmonyair g-series lighting system detached and fell during a patient procedure.The yoke cover fell into the sterile field.The affected instruments were replaced, there was no impact to the patient, and the procedure was completed successfully without report of delay.The lighting system was removed from service awaiting onsite inspection.
Additional Manufacturer Narrative
The steris service technician arrived onsite to inspect the harmonyair g-series lighting system and confirmed the yoke cover was damaged.The technician confirmed the damage is attributed to user facility personnel bumping the lighthead into walls or other equipment.The steris service technician replaced the lighthead cover, tested the unit, confirmed it was operating according to specification, and returned it to service.The harmonyair g-series gen2 operator manual ((b)(4)) documents the following statements within the safety precautions section, "warning - personal injury and/or equipment damage hazard avoid damage after collisions.The monitor mount may become damaged and fail if it collides with other objects, walls, or ceilings.Check the monitor mount for potential damage after collisions.Inform the operator if in doubt.Caution - possible equipment damage.Do not bump lightheads into walls or other equipment.Avoid damage to the monitor mount.To avoid damage to the monitor mount: do not use force when moving the monitor mount into the limit positions.Avoid collisions with other components." steris clinical support representative counseled user facility personnel on the proper use and operation of the lighting system, specifically on how to move the lightheads to avoid bumping into walls or other equipment.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 19941621
• Report Number: 1043572-2024-00053
• Device Sequence Number: 20673060
• Product Code: FSY
• UDI-Device Identifier: 00724995207595
• UDI-Public: (01)00724995207595
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: G-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LG05V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 08/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown