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	11/30/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported the light handle of their harmonyair a-series lighting system is detaching and falling during use.Injuries or procedure delays were reported.
Additional Manufacturer Narrative
A steris field service technician arrived onsite to inspect the lighting system and found the light handle was not properly locking into position when installed on the lighthead resulting in the reported event.The lighting system has been removed from service pending repairs.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported the light handle of their harmonyair a-series lighting system is detaching and falling during use.No injuries or procedure delays were reported.
Additional Manufacturer Narrative
The investigation determined that the light handle locking mechanism was not fully engaged resulting in the reported event.The technician replaced the light handle, tested the unit, confirmed it to be operation according to specifications and returned it to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• 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: 16062815
• Report Number: 1043572-2022-00094
• Device Sequence Number: 20509557
• Product Code: FSY
• UDI-Device Identifier: 00724995188467
• UDI-Public: 00724995188467
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/28/2022

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: LAS01IN01
• 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: 11/30/2022
• Supplement Date Received by Manufacturer: 11/30/2022
• Initial Report FDA Received Date: 12/28/2022
• Supplement Report FDA Received Date: 03/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/05/2022
• 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