MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY 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	09/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the lighting system and found that the yoke assembly had come loose from the female adapter resulting in the reported event.The technician replaced the dual monitor yoke assembly, tested the unit, confirmed to be operating according to specifications, and returned it to service.The damaged parts were returned to montgomery for engineering to review.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that their dual monitor yoke assembly detached from the suspension arm of their harmonyair a-series surgical lighting system and was hanging by the wiring within the light.There was no one in the room at the time of the reported event.No report of injury or procedural delay.
Additional Manufacturer Narrative
The damaged yoke assembly was returned for evaluation.A root cause of the reported event could not be determined.Steris will continue to monitor for similar events.

• Brand Name: HARMONYAIR A-SERIES SURGICAL LIGHTING SYSTEM
• Common Device Name: 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: 15651222
• Report Number: 1043572-2022-00070
• Device Sequence Number: 6241139
• Product Code: FSY
• UDI-Device Identifier: 00724995187637
• UDI-Public: 00724995187637
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/21/2022

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: LAH11IN02
• 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: 09/23/2022
• Supplement Date Received by Manufacturer: 09/23/2022
• Initial Report FDA Received Date: 10/21/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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