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	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the harmonyair m-series surgical lighting system and found the internal snap ring which attaches the lighthead to the spring arm had detached from where installed resulting in the reported event.The unit is not under steris service agreement for maintenance activities; the user facility is responsible for all maintenance activities.The service technician is awaiting parts to replace the entire detached lighthead assembly.A follow-up mdr will be submitted should additional information become available.
Event or Problem Description
The user facility reported that a lighthead detached and had fallen from their harmonyair m-series surgical lighting system.There was no patient in the room at the time of the reported event.No report of injury.
Additional Manufacturer Narrative
Based on the results of the investigation, the cause of the snap ring detaching is unknown.The technician replaced the light head, tested the unit, confirmed it to be operating according to specifications, and returned it to service.A 2-year complaint review indicate this to be an isolated event.No additional issues have been reported.

• Brand Name: HARMONYAIR M-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: 15737093
• Report Number: 1043572-2022-00077
• Device Sequence Number: 11477865
• Product Code: FSY
• UDI-Device Identifier: 00724995191542
• UDI-Public: 00724995191542
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 11/04/2022

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: M-SERIES SURGICAL LIGHTING SYSTEM
• Device Catalogue Number: LMH01
• 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: 10/05/2022
• Supplement Date Received by Manufacturer: 10/05/2022
• Initial Report FDA Received Date: 11/04/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2018
• 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