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

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

Patient Problem Injury (2348)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance 444 washer and found the unit to be operating properly.No repairs were required, and the unit was returned to service.The technician spoke with user facility personnel and was informed that the employee attempted to unload the washer after initiating standby mode.Standby mode should be used when the washer will not be used for an extended period of time.During standby mode there is a 1 minute countdown before the standby cycle starts to allow operators to cancel standby cycle.After the countdown is completed the door closes.After the employee initiated standby mode, they began unloading the unit.While unloading, the countdown ended, and the door closed contacting the employee's arm.The root cause of this event is attributed to user error as the employee tried to unload the washer while in standby mode.The technician counseled user facility personnel on the proper use and operation of the unit and safety protocols, specifically to not unload the washer after initiating standby mode.A 2-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

Hold for r.G.1.20 the user facility reported an employee obtained an injury to their arm while unloading their reliance 444 washer.Medical treatment was sought.No medical treatment was administered.

• Brand Name: RELIANCE 444 WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 10996686
• MDR Text Key: 228350759
• Report Number: 9680353-2020-00039
• 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: 12/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2020
• 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: 11/12/2020
• 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