MAUDE Adverse Event Report: CORPORATION STERIS CANADA RELIANCE VISION; RELIANCE VISION MULTI-CHAMBER WASHER DISINFECTOR

Model Number	MULTI-CHAMBER
Medical Device Problem Code	Application Program Problem (2880)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the reliance vision multi-chamber washer/disinfector and found no issues with the function or operation of the unit and no repairs were required.However, the technician confirmed that the digital printout for the cycle count had a dash in front of the cycle number when downloaded on a computer separate from the unit.The unit had and was continuing to record the correct cycle count.There is no impact on the function or operation of the unit.The technician returned the unit to service.No additional issues have been reported.
Event or Problem Description
The user facility reported via vigilance report that their reliance vision multi-chamber washer/disinfector experienced a "digital printout problem".No report of injury.

• Brand Name: RELIANCE VISION
• Common Device Name: RELIANCE VISION MULTI-CHAMBER 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: 21728759
• Report Number: 9680353-2025-00016
• Device Sequence Number: 17155418
• Product Code: MEC
• UDI-Device Identifier: 00724995193171
• UDI-Public: (01)00724995193171(11)170216
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/30/2025

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: MULTI-CHAMBER
• Device Catalogue Number: FH83062
• 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: 02/28/2025
• Initial Report FDA Received Date: 03/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2017
• 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