MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE 444 WASHER/DISINFECTOR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 04/12/2022

Event Type  malfunction  

Event Description

The user facility reported that an employee was removing a rack that became jammed in their reliance 444 washer and while removing the rack, the washer door contacted the employee's hand.The employee sought medical treatment.

Manufacturer Narrative

A steris service technician arrived on site and found the washer to be operating properly.No issues were noted with the function or operation of the washer and the washer was returned to service.The employee subject of the reported event improperly positioned the rack inside the washer.The employee then hit the "door close" button and observed the jam.She reached into the washer to align the rack and in the process the washer door contacted her hand.The reliance 444 washer operator manual states (1-1), "if an obstruction is present in the wash chamber door, door safety sensor will detect obstruction and door will automatically stop closing.Wait until door is fully open and water flow has stopped before removing obstruction." "if an obstruction is present in the wash chamber door and door is unable to raise, do not attempt to remove obstruction from under the door.Door cables may have slackened and door may close at high speed when obstruction is removed.Call a qualified service technician to safely remove obstruction." the steris technician counseled personnel on proper operating procedures for the washer racks, specifically proper loading practices.No additional issues have been reported.

• Brand Name: RELIANCE 444 WASHER/DISINFECTOR
• Type of Device: 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: 14361255
• MDR Text Key: 291513634
• Report Number: 9680353-2022-00015
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1