MAUDE Adverse Event Report: STERIS CORPORATION - MONTGOMERY HARMONYAIR MONITOR CARRIER

Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris account manager was informed that the ems system was installed by a third-party service provider.A steris service technician arrived onsite to inspect the harmonyair monitor carrier and confirmed the reported event.The cause of the event can be contributed to the size of the screws used to install the harmonyair montior carrier (25mm instead of 30mm).A new ems system was installed at the customer's location.The unit was tested and confirmed it to be operating according to specification.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that their harmonyair monitor carrier detached from the ems system.The event did not occur during a patient procedure; however, it was reported that procedures were postponed as the room could not be used.No report of injury.

• Brand Name: HARMONYAIR MONITOR CARRIER
• Common Device Name: MONITOR CARRIER
• Manufacturer (Section D): STERIS CORPORATION - MONTGOMERY; 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: 19387492
• Report Number: 1043572-2024-00035
• Device Sequence Number: 6875909
• Product Code: FQO
• UDI-Device Identifier: 00724995153663
• UDI-Public: 00724995153663
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/23/2024

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
• 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: 04/25/2024
• Initial Report FDA Received Date: 05/23/2024
• 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