MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; HARMONYAIR M-SERIES 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	03/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
User facility personnel stated that the screw fell onto a prepped stand next to the table and did not contact the patient.A steris service technician arrived onsite following the reported event and found that user facility personnel had already repaired the lighting system.As user facility personnel performed the service activity prior to the technician's arrival, a root cause as to why the screw fell from lighting system could not be determined.The reported event may be attributed to personnel bumping the lighting system into walls or other equipment.The operator manual states, "sec.1 - 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." the technician counseled user facility personnel on the proper use and operation for the lighting system specifically, not bumping the lightheads into walls or other equipment.The technician verified the lighting system was operating properly and no additional repairs were made.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a screw fell from their harmonyair m-series lighting system into the sterile field.No report of injury or procedure delay.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR M-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: 21937069
• Report Number: 1043572-2025-00045
• Device Sequence Number: 17481773
• Product Code: FSY
• UDI-Device Identifier: 00724995166090
• UDI-Public: (01)00724995166090(11)161011
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 04/30/2025

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: LMH12N
• 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: 04/01/2025
• Initial Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/11/2016
• 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