MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; LIGHTING SYSTEM

Model Number	G-SERIES LIGHTING SYSTEM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the harmonyair g-series dual light and found that the front joint cover was damaged which caused portions of that cover to break off onto the sterile field.The technician made the necessary repairs to the light and replaced the front joint cover.The root cause of the reported event is likely contributed by physical impact upon the lighting system that caused damage and the detachment of the affected cover components.The harmonyair g-series gen2 operator manual states (1-1), "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." the harmonyair g-series gen2 operator manual states (1-5), "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." a steris account manager completed in-service training with the customer on how to properly move the lights avoiding collision on 9/10/2024.No additional issues have been reported.
Event or Problem Description
The user facility reported during a patient procedure that a piece of plastic detached from their harmonyair g-series dual light and fell onto the sterile field.No report of injury or procedure delay.

• 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: 20238684
• Report Number: 1043572-2024-00063
• Device Sequence Number: 18165210
• 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): 09/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 08/19/2024
• Initial Report FDA Received Date: 09/17/2024
• 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