MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 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	04/18/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found that the cover had been damaged.This is indicative of facility personnel bumping the lighthead into other pieces of equipment.A steris tech inspected and confirmed that biomed replaced the broken cover and installed it properly.The unit was tested, confirmed it to be operating according to specification, and returned it to service.The operator manual states (1-4), "do not bump light heads into walls or other equipment." the technician replaced the broken cover, tested the lighting system, confirmed it was operating according to specification, and returned it to service.A steris account manager offered in-service training regarding the proper use and operation of the harmonyair m-series surgical lighting system, specifically avoiding collision with walls or other equipment in the room; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure an end cover detached from their harmonyair m-series surgical lighting system and fell into the sterile field.A procedure delay occurred as the sterile field was re-established.The procedure was completed successfully, and no injury was reported.

• Brand Name: HARMONYAIR M-SERIES SURGICAL LIGHTING SYSTEM
• Common Device Name: SURGICAL LIGHTING SYSTEM
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer (Section G): STERIS CORPORATION - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 16947897
• Report Number: 1043572-2023-00101
• Device Sequence Number: 6554838
• Product Code: FSY
• UDI-Device Identifier: 00724995165918
• UDI-Public: 00724995165918
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/17/2023

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: LM01N
• 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: 04/18/2023
• Initial Report FDA Received Date: 05/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2017
• 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