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

Model Number	1227
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation of the subject event is in process.A follow-up mdr will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that two employees obtained injuries after operating their reliance 1227 cart washer.
Additional Manufacturer Narrative
The customer had previously been informed that the space on the load side of the unit is smaller than recommended.This can make it difficult for loading carts to be aligned correctly and can potentially cause the cart to shift during the wash cycle making it the cart difficult to unload.The root cause of the reported event is attributed to the user facility personnel attempting to lift the utensil carts back onto the alignment guides before unloading.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.
Event or Problem Description
The user facility reported that two employees were injured while trying to align the utensil carts back onto the alignment guides of their 1227 cart washer.

• 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 road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13715739
• Report Number: 9680353-2022-00007
• Device Sequence Number: 20426474
• Product Code: MEC
• UDI-Device Identifier: 00724995193430
• UDI-Public: 00724995193430
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2022

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
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2022
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 03/09/2022
• Supplement Report FDA Received Date: 04/28/2022
• 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