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	09/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived on site to inspect the monitor carrier and was able to determine that the plastic cover was not fully attached to the underside of the monitor spring arm.The technician snapped the cover pieces together and verified they were secure.Additionally, the technician examined all cover pieces within the room to ensure they were also secure.After making appropriate adjustments and testing all equipment within the room, the technician confirmed the units to be operating according to specification.The technician was re-trained on proper installation activities for the harmonyair monitor carrier with specific focus on proper cover installation.No additional issues have been reported.
Event or Problem Description
The user facility reported that the plastic cover to their harmonyair monitor carrier fell off during use.No report of procedure delays/cancellations.No report of injury.
Additional Manufacturer Narrative
Udi related data quality updates only: alignment with gudid.The serial number listed in mdr 1043572-2023-00144 was incorrect by one digit.The serial number was corrected in mdr 1043572-2023-00144-01.

• Brand Name: HARMONYAIR
• Common Device Name: HARMONYAIR 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: 17884983
• Report Number: 1043572-2023-00144
• Device Sequence Number: 7429630
• 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
• Report Date (Section B): 10/06/2023

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: 09/07/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 01/22/2025
• 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