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

Model Number	E-SERIES
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pain (1994)
Date of Event	04/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Following the procedure, user facility personnel confirmed the patient did not sustain a bruise or an injury due to the reported event.A steris service technician arrived onsite following the event to inspect the lighting system.During the technician's inspection he found one of the spring arms was not holding position and the safety locking pin was missing.Through follow-up, the technician learned that prior to the reported event, user facility personnel had removed the safety locking pin in order to adjust the tension/positioning of the spring arm.User facility personnel then placed the spring arm upon the monitor arm so it was out of the way.When the patient was being transferred, the monitor arm was bumped subsequently causing the spring arm to "swing down" resulting in the reported event.The harmonyair surgical lighting system e-series is not under a steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The technician removed the spring arms from service and is awaiting new spring arms prior to the lighting system being returned to service.A follow-up report will be submitted once all service activity is completed, and the lighting system is returned to service.
Event or Problem Description
The user facility reported that while a patient was sitting upwards being transferred from a gurney to the surgical table, a spring arm from their harmonyair surgical light system "swung down" subsequently causing the lighthead to contact the patient's forehead.User facility personnel proceeded with the procedure and the procedure was completed successfully.
Additional Manufacturer Narrative
The steris service technician installed new spring arms, tested the function and operation of the lighting system and returned the unit to service.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR SURGICAL LIGHTING SYSTEM E-SERIES
• 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: 22104809
• Report Number: 1043572-2025-00053
• Device Sequence Number: 7356288
• Product Code: FSY
• UDI-Device Identifier: 00724995173807
• UDI-Public: (01)00724995173807(11)200109
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 05/29/2025

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: E-SERIES
• Device Catalogue Number: LES01IN01T
• 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: 04/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/29/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/09/2020
• 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