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	01/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the lighting system and found the lighthead cover broken and requiring replacement.The observed damaged is indicative of impact damage caused by user facility personnel bumping the lighthead into the wall or other equipment.The technician replaced the lighthead cover and confirmed the unit was operational.The lighting system was returned to service.The harmonyair m-series surgical lighting system operator manual states, "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." the technician counseled user facility personnel on the importance of being careful not to bump the surgical lights into other equipment.No additional issues have been reported.
Event or Problem Description
The user facility reported a piece to the surgical lighthead cover to their harmonyair m-series surgical lighting system fell off during procedure.The user facility quickly reestablished the sterile field by covering the broken piece with a sterile towel and proceeding with the procedure.Procedure was completed successfully without delay; no report of injury.

• 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: 21433392
• Report Number: 1043572-2025-00019
• Device Sequence Number: 11852456
• Product Code: FSY
• UDI-Device Identifier: 00724995191566
• UDI-Public: (01)00724995191566(11)180913
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 02/21/2025

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: M-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LMH02
• 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
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2018
• 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