MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE 1227 CART AND UTENSIL WASHER/DISINFECTOR

Model Number	1227
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that their 1227 reliance cart and utensil washer/disinfector was leaking onto the floor causing an employee to slip.No report of injury.No medical treatment was sought of administered.
Additional Manufacturer Narrative
A steris service technician arrived at the facility, inspected the washer and found that the gasket on the heat exchanger was cracked.As the gasket on the heat exchanger was cracked, this allowed steam to leak from the unit.The steam valve was stuck in the open position allowing steam to flow into the heat exchanger which is what caused the gasket to crack.The technician made the necessary repairs, ran a test cycle, confirmed the unit to be operating according to specification and returned the unit to service.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

• Brand Name: RELIANCE 1227 CART AND UTENSIL 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: 16904406
• Report Number: 9680353-2023-00013
• Device Sequence Number: 17852118
• Product Code: MEC
• UDI-Device Identifier: 00724995193430
• UDI-Public: 00724995193430
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 05/10/2023

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: 04/12/2023
• Initial Report FDA Received Date: 05/10/2023
• 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