MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; LIGHTING SYSTEM

Model Number	A-SERIES LIGHTING SYSTEM
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that paint on multiple lightheads to their harmonyair a-series surgical lighting systems are chipping and peeling.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair a-series surgical lighting systems and found that paint was chipping and peeling on four lightheads; (b)(4).The reported paint chipping and peeling is attributed to improper cleaning practices by user facility personnel, specifically not properly drying the equipment after cleaning.The operator manual states (8.1), "operator manual maintenance 8.1 cleaning equipment warning-personal injury hazard: do not attempt to clean lighthead unless power is turned off and the lighthead has cooled sufficiently.Caution-possible equipment damage: use of any disinfectant solution other than those listed here may cause discoloration or deformation on the lens surface and other system components[?]"."the use of h2o2 + paa (hydrogen peroxide + peracetic acid) is strongly discouraged for use on all steris products.Always follow manufacturer instructions for concentrations and use of cleaning products.Do not spray any cleaning product directly onto the lighthead, integrated wall control (iwc) or any system components.Clean iwc screen with a clean, lint-free cloth dampened with 90% isopropyl alcohol.For other system components, dampen a clean, soft cloth with the cleaning solution and wring out the excess moisture." a steris account manager counseled user facility personnel on the importance of following proper cleaning practices for their lightheads.The light heads have been removed from service to await installation of new lightheads that have been ordered by the customer.A follow up mdr will be submitted once new information becomes available.
Additional Manufacturer Narrative
A steris service technician installed the new light heads and placed them into service.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: 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
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 20259922
• Report Number: 1043572-2024-00064
• Device Sequence Number: 18033404
• Product Code: FSY
• UDI-Device Identifier: 00724995188467
• UDI-Public: (01)00724995188467(11)220725
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: 08/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2022
• 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