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

Model Number	M-SERIES SURGICAL 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	01/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The light of the reported event has been removed from service pending further investigation.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported during a patient procedure that the plastic light head cover detached from their harmonyair m-series surgical lighting system as the light head was repositioned and the light head cover fell onto an instrument stand.No report of injury or procedure delay.
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the lighting system and found the screws that are used to secure the plastic covers were missing.It is unknown how the screws were displaced from their position.The most likely cause is user facility bumping the lights into walls or other equipment.To resolve the issue, the technician installed a new light head cover kit and secured new screws to the light head.The technician tested the light, confirmed the lighting system to be operating according to specification, and returned it to service.The harmonyair m-series surgical lighting system is not under steris service agreement for preventive maintenance activities; the user facility is responsible for all maintenance activities.The technician counseled user facility personnel on the importance how not to bump the lightheads onto other objects while repositioning the lights.The harmonyair m-series surgical lighting system operator manual states, "safety precautions: 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." no additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR M-SERIES SURGICAL 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: 21441027
• Report Number: 1043572-2025-00020
• Device Sequence Number: 4683906
• Product Code: FSY
• UDI-Device Identifier: 00724995191573
• UDI-Public: (01)00724995191573(11)200721
• 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): 02/22/2025

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: M-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LMH02T
• 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: 01/23/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2025
• Supplement Report FDA Received Date: 04/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2020
• 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