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

Model Number	1227
Medical Device Problem Code	Display or Visual Feedback Problem (1184)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow up with user facility personnel, it was discovered that the computer of the disinfector stopped working and the screen was black.The user facility elected to make the repairs themselves, and the washer was returned to service.A cause of the event could not be determined as the user facility declined service from a steris service technician.The washer is not under steris service agreement for maintenance; the user facility is responsible for all maintenance activities.Contrary to the user facility's report, steris is not aware of any "known issues" related to the hardware of the reliance 1227 cart washer.A 3-year complaint review indicates this to be an isolated event.Steris evaluated the reported event and determined it does not meet our reporting criteria under 21 cfr part 803.It should be noted that steris is submitting a medical device report (mdr) solely due to the receipt of the user facility medwatch report which is in accordance with our procedures and policies.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report #(b)(4) that "computer on the cart washer suffered an error believed to be a failing hard drive.".

• Brand Name: RELIANCE
• Common Device Name: RELIANCE 1227 CART AND 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 ; 4402597401
• MDR Report Key: 23850381
• Report Number: 9680353-2025-00051
• Device Sequence Number: 21225525
• Product Code: MEC
• UDI-Device Identifier: 00724995193447
• UDI-Public: (01)00724995193447(11)170316
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 12/19/2025

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: 1227
• Device Catalogue Number: FW03102
• 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: 11/19/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/16/2017
• 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