MAUDE Adverse Event Report: STERIS CORPORATION 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	04/29/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event and confirmed the cover was detached and required re-install.The technician re-installed the cover, tested the function and operation of the harmonyair monitor carrier, confirmed it to be operating to specification and returned the unit to service.The harmonyair monitor carrier is not under steris service agreement for preventive maintenance activities.The user facility is responsible for all maintenance activities.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure an employee was moving the monitor carriage to their harmonyair monitor carrier into position and contacted the lower boom causing the monitor carriage cover to detach.A short procedure delay was reported.No report of injury.

• Brand Name: HARMONYAIR
• Common Device Name: MONITOR CARRIER
• 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 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4402597401
• MDR Report Key: 25318981
• Report Number: 1043572-2026-00053
• Device Sequence Number: 20147287
• Product Code: FQO
• UDI-Device Identifier: 00724995153380
• UDI-Public: (01)00724995153380
• 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): 05/28/2026

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: HCLP120004
• 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: 04/29/2026
• Initial Report FDA Received Date: 05/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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