MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; EMS BOOM

Model Number	HARMONYAIR CEILING BOOMS
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	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site following the reported event to inspect the unit and confirmed that the cover had detached.The cause of the reported event is attributed to user facility personnel bumping the harmonyair ems boom into other equipment.The unit subject of the reported event is pending repairs.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure the cover of their harmonyair ems boom was falling off.The procedures were completed successfully.No report of injury.
Additional Manufacturer Narrative
To resolve the issue, the technician replaced the cover.The unit was tested, confirmed to be operating according to specification, and returned to service.While onsite, the technician counseled user facility personnel on the proper use and operation of the harmonyair ems boom, specifically on proper handling of the device.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: EMS BOOM
• Manufacturer (Section D): STERIS CORPORATION; 2720 gunter park drive east; montgomery 36109
• Manufacturer (Section G): STERIS CORPORATION; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 23794969
• Report Number: 1043572-2025-00113
• Device Sequence Number: 20220401
• Product Code: FQO
• UDI-Device Identifier: 00724995156718
• UDI-Public: (01)00724995156718(11)240906
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 12/12/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: HARMONYAIR CEILING BOOMS
• Device Catalogue Number: HMSLM
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 01/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/06/2024
• 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