MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; A-SERIES LIGHTING SYSTEM

Model Number	A-SERIES LIGHTING SYSTEM
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the reported event is in progress; a follow-up report will be submitted when additional information becomes available.Udi related data clarification - the lot/serial number is unknown, therefore, the applicable production identifiers were not included in the mdr.
Event or Problem Description
The user facility reported during a patient procedure their harmony air a-series surgical lighting system experienced a loss of control of the lights and had to restart the system at the wall control resulting in a short procedure delay.No report of injury.
Additional Manufacturer Narrative
There are two serial numbers subject of the event:(b)(6).A steris service technician arrived onsite to inspect the lighting systems.Functional testing of the lighting systems was completed.The technician updated the system's software, tested the lighting systems, confirmed them to be operating according to specification, and returned them to service.A 3-year complaint review confirmed this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported during two patient procedures their harmonyair a-series surgical lighting systems experienced a loss of control of the lights and had to restart the system at the wall control resulting in short procedure delays.No report of injury.

• Brand Name: HARMONYAIR
• Common Device Name: A-SERIES 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: 21160925
• Report Number: 1043572-2025-00005
• Device Sequence Number: 8520484
• Product Code: FSY
• UDI-Device Identifier: 00724995186074
• UDI-Public: (01)00724995186074(11)230613
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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
• 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: 12/16/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/15/2025
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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