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

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/31/2015

Event Type  No Answer Provided  

Manufacturer Narrative

A user facility employee started a washing cycle and left the room.Upon return, the employee stated the load door was open and the fan blower was running.The washer did not display an alarm at the time of the reported event.No injuries were reported.User facility personnel attempted to close the door with the display board but it would not respond.Shortly after, the load and unload doors, opened and closed several times without being instructed to do so.A steris service technician arrived on-site, inspected the unit, but was unable to duplicate the reported event.Although the technician was unable to duplicate the reported event, the technician replaced the control board and confirmed the unit to be operating according to specification.No additional issues have been reported.Prior to the reported event, the reliance 444 washer required service as the pure water rinse tank overheated.The rtd temperature sensor on the pure water rinse tank was replaced.The pure water rinse tank is contained within the reliance 444 washer.If the tank overheats, it can cause the temperature within the unit to raise and push steam out of the top cover of the tank.This can cause condensation inside the stainless steel box which holds the control board, which can lead to the control board short circuiting due to the excess steam.

Event Description

The user facility reported that the load door opened when the reliance 444 was in the dry phase of the washing cycle.Procedural delays were reported as a result of the event.No injuries were reported.

• Brand Name: RELIANCE 444 WASHER/DISINFECTOR
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8 A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5239918
• MDR Text Key: 32034976
• Report Number: 9680353-2015-00078
• 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
• Type of Report: Initial
• Report Date: 11/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/02/2015
• 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