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	10/11/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the harmonyair monitor carrier and found the retention latches on the front cap cover to be damaged.As the retention latches were damaged, this caused the cover to detach and fall.The technician installed a new cap cover, tested the function and operation of the harmonyair monitor carrier, and confirmed it to be operational; the unit was returned to service.Through follow-up with user facility technicians, user facility personnel were raising the monitor carrier too high towards the ceiling subsequently causing the device to contact the ceiling.The damaged observed to the cap cover retention latches can be attributed to the device impacting the ceiling.The operator manual states (pg.12), "caution - possible equipment damage -avoid damage to equipment by articulating (do not approach stops roughly; avoid collisions with other equipment) the equipment slowly and evenly." the steris account manager offered in-service training on the proper use and operation of the harmonyair monitor carrier and is awaiting a response.No additional issues have been reported.
Event or Problem Description
The user facility reported that during a patient procedure a cap cover from their harmonyair monitor carrier detached and fell into the sterile field subsequently causing a procedure delay.The sterile field was reestablished, and the patient procedure was completed successfully.No report of injury.
Additional Manufacturer Narrative
The steris account manager counseled the user facility personnel on the proper use and operation for the harmonyair monitor carrier specifically not bumping the device into other equipment or ceiling.
Additional Manufacturer Narrative
Udi related data quality updates only - alignment with gudid.

• 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 - MONTGOMERY; 2720 gunter park drive east; montgomery AL 36109
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 18112244
• Report Number: 1043572-2023-00160
• Device Sequence Number: 7863352
• Product Code: FQO
• UDI-Device Identifier: 00724995153472
• UDI-Public: (01)00724995153472(11)230123(21)0423R003585655
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Followup
• Report Date (Section B): 11/10/2023

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: HCLP160001
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 10/11/2023; Not provided
• Initial Report FDA Received Date: 11/10/2023
• Supplement Report FDA Received Date: 01/11/2024; 01/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/23/2023
• 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