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	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the connect point of their harmonyair m-series surgical lighting system became loose, drifting down striking the anesthesiologist on the head.There were no reports of injury nor any procedural delays/cancellations involving this event.The intended procedure was completed successfully.
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the harmonyair m-series surgical lighting system and found that the friction brake adjustments used to hold the connect point in place had become loose and did not work as intended.The harmonyair m-series surgical lighting system is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.This unit was installed in 2017 making it approximately 6 years old at the time of the reported event.The harmonyair m-series surgical lighting system operator manual states (8-1), "preventative maintenance is essential in keeping this equipment in optimal working condition.Steris recommends establishing an annual maintenance agreement with steris service.Note: maintenance is necessary to maintain basic safety and essential performance, including emc performance".The technician replaced the connect point, confirmed the unit to be operating according to specification, and returned the unit to service.No additional issues have been 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
• MDR Report Key: 17137823
• Report Number: 1043572-2023-00118
• Device Sequence Number: 14945469
• Product Code: FSY
• UDI-Device Identifier: 00724995191566
• UDI-Public: 00724995191566
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Report Date (Section B): 06/15/2023

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: 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: 05/22/2023
• Initial Report FDA Received Date: 06/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/07/2016
• 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