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

Model Number	1227
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the reliance 1227 cart and utensil washer/disinfector.The technician ran multiple test cycles and was unable to duplicate the reported event.No issues were noted with the function or operation of the device and was confirmed to be operating to specifications.During the technician's inspection, it was found that the user facility's sprinkler head was set at 155°f instead of 260°f.It is the user facility's responsibility for their sprinkle head settings.During install of the reliance 1227 cart and utensil washer/disinfector, user facility personnel were advised that the sprinkler head settings must be fused to 260°f or above.The steris account manager counseled user facility personnel on the importance of sprinkler head settings.The technician returned the reliance 1227 cart and utensil washer/disinfector to service, and no additional issues have been reported.
Event or Problem Description
The user facility reported that when the door to their reliance 1227 cart and utensil washer/disinfector was opened following a completed cycle, steam and vapor came out causing the facility's sprinkler system to be set off.Patient procedures were subsequently postponed.No report of injury.

• Brand Name: RELIANCE
• Common Device Name: 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 ; 4402597401
• MDR Report Key: 23780831
• Report Number: 9680353-2025-00049
• Device Sequence Number: 18684605
• Product Code: MEC
• UDI-Device Identifier: 00724995193430
• UDI-Public: (01)00724995193430(11)180322
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/11/2025

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: 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: 11/12/2025
• Initial Report FDA Received Date: 12/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/22/2018
• 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