MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; LIGHTING SYSTEM

Model Number	A-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	06/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and determined that the external retaining ring to the light handle assembly was damaged resulting in the reported event.The lighting system subject of the reported event is not under a steris service contract for preventive maintenance.The user facility is responsible for all maintenance activities.A steris service technician replaced the light head subject of the reported event, tested the unit, confirmed it to be operating according to specifications, and returned it to service.No additional issues have been reported.
Event or Problem Description
The user facility reported that their light handle assembly detached from a harmonyair a-series light head prior to a procedure.The handle assembly did not fall but rather remained connected to and supported by the light head wire harness.The procedure was completed successfully.No report of injury.

• Brand Name: HARMONYAIR
• Common Device Name: LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 22523363
• Report Number: 1043572-2025-00065
• Device Sequence Number: 8560432
• Product Code: FSY
• UDI-Device Identifier: 00724995187989
• UDI-Public: (01)00724995187989(11)230308
• 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): 07/16/2025

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: A-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAH11IN02
• 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: 06/20/2025
• Initial Report FDA Received Date: 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/08/2023
• 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