MAUDE Adverse Event Report: STERIS CORPORATION HARMONYAIR; HARMONYAIR MONITOR CARRIER

Model Number	MONITOR CARRIER
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	07/10/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the plastic cover to their harmony air monitor carrier detached and fell off.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and confirmed that the cover detached.The reported event is indicative of impact damage caused by user facility personnel bumping the lighthead into walls or other equipment.The technician reattached the cover, tested the unit, confirmed the unit to be operating according to specification, and returned it to service.The harmonyair monitor carrier operator manual states, "possible equipment damage: avoid damage to equipment by articulating (do not approach stops roughly; avoid collisions with other equipment) the equipment slowly and evenly." user facility personnel were counseled on equipment placement and storage management for the harmonyair monitor carrier.No additional issues have been reported.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR MONITOR CARRIER
• 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: 22743057
• Report Number: 1043572-2025-00073
• Device Sequence Number: 12645808
• Product Code: FQO
• UDI-Device Identifier: 00724995153663
• UDI-Public: (01)00724995153663(11)240327
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 08/07/2025

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: MONITOR CARRIER
• Device Catalogue Number: HCES160005
• 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: 07/10/2025
• Initial Report FDA Received Date: 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2024
• 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