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

Model Number	A-SERIES 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
Event or Problem Description
The user facility reported that during a patient procedure user facility personnel heard a "crack" and observed the harmonyair a-series surgical lighting system canopy cover had slid down the spindle arm.The procedure was completed successfully, and no injuries were reported.
Additional Manufacturer Narrative
Following the reported event, steris inspected the harmonyair a-series surgical lighting system and found that the canopy ring was damaged.As the canopy ring was damaged this allowed the canopy cover to lower from its location and move down the spindle arm.The spindle arm was not impacted during the reported event and the surgical lighting system did not move.The damaged canopy ring may be attributed to overtightening during installation of the harmonyair a-series surgical lighting system or unknown impact the canopy ring sustained prior to the reported event.The steris installation team and service have been made aware of the reported event.The canopy ring was replaced, and the lighting system was operating to specifications.The harmonyair a-series surgical lighting system was returned to service, and no additional issues have been reported.A complaint review was performed and confirmed this to be an isolated event.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR A-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: 21432240
• Report Number: 1043572-2025-00017
• Device Sequence Number: 11897417
• Product Code: FSY
• UDI-Device Identifier: 00724995186326
• UDI-Public: (01)00724995186326(11)240228
• 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): 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: A-SERIES LIGHTING SYSTEM
• Device Catalogue Number: LAH24INND
• 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: 01/22/2025
• Initial Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2024
• 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