MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION MULTI-CHAMBER WASHER/DISINFECTOR

Model Number	MULTI-CHAMBER
Medical Device Problem Codes	Application Program Problem (2880); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported via vigilance report that their reliance vision multi-chamber washer/disinfector is experiencing a "computer software problem".No report of injury.
Additional Manufacturer Narrative
Investigation of this event is currently in process.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The steris service specialist inspected the reliance vision multi-chamber washer/disinfector and found that the cycle count required resetting.No issues were noted with the function or operation of the unit.The steris service specialist reset the cycle count, tested the function and operation of the reliance vision multi-chamber washer/disinfector and confirmed the unit to be operating properly.The reliance vision multi-chamber washer/disinfector was returned to service and no additional issues have been reported.A complaint review was conducted a confirmed the reported event to be isolated.

• Brand Name: RELIANCE VISION MULTI-CHAMBER WASHER/DISINFECTOR
• Common Device Name: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley rd; mentor, OH 44060 ; 4403927453
• MDR Report Key: 17037701
• Report Number: 9680353-2023-00015
• Device Sequence Number: 6412937
• Product Code: MEC
• UDI-Device Identifier: 00724995193171
• UDI-Public: 00724995193171
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 05/03/2023
• Supplement Date Received by Manufacturer: 05/03/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 09/06/2023
• 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