MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE; RELIANCE 1227 CART AND UTENSIL WASHER DISINFECTOR

Model Number	1227
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Codes	Aspiration/Inhalation (1725); Eye Irritation (4803)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the unit and found no issues with its function or operation.The reported event could not be duplicated.During follow-up with user facility personnel, the technician confirmed that the sterile processing department technicians were utilizing an enzyme detergent instead of a neutral or alkaline detergent.Utilizing an enzyme detergent may result in a "fume" smell during a cycle.The reliance 1227 cart and utensil washer disinfector operator manual instructs users the need to utilize a neutral or alkaline detergent.The technician replaced the enzyme detergent with a neutral detergent, confirmed the unit was operating to specifications, and returned it to service.The technician counseled user facility personnel on the proper use and operation of the reliance 1227 cart and utensil washer disinfector, specifically the importance of utilizing the proper detergent.A complaint review has determined this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that employees experienced inhalation and eye irritation during a cycle for their reliance 1227 cart and utensil washer disinfector.The employees sought treatment at the facility's emergency room; however, it is unknown what treatment may have been received.

• Brand Name: RELIANCE
• Common Device Name: RELIANCE 1227 CART AND UTENSIL WASHER DISINFECTOR
• Manufacturer (Section D): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): CORPORATION STERIS CANADA; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060
• MDR Report Key: 21660320
• Report Number: 9680353-2025-00010
• Device Sequence Number: 15688526
• Product Code: MEC
• UDI-Device Identifier: 00724995193430
• UDI-Public: (01)00724995193430(11)170609
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 03/20/2025

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
• Device Model Number: 1227
• Device Catalogue Number: FW03101
• 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: 02/18/2025
• Initial Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2017
• 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