MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE SYNERGY WASHER

Device Problems Device Emits Odor (1425); Loss of Power (1475); Smoking (1585)

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

Event Date 01/07/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their washer shutdown and emitted a burning smell and smoke.No injuries or procedural delays or cancellations were reported.No evacuations were required.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified melted electrical and plumbing components underneath the sump.The technician's inspection determined the melted connections were most likely caused by a closed contactor which allowed for a continuous current to run through the heater element.The over-temperature switch (ots) is designed to shut down the controller and thus the heater elements de-energize.The ots had been tripped, the controller shut down, but the heater elements were still energized.Because the heater elements had not de-energized, it is most likely there was a contactor malfunction which allowed the heater element to stay in the "on" position.The unit has not been returned to service because the customer has made the decision to replace the unit.

• Brand Name: RELIANCE SYNERGY WASHER
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; beauport, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; beauport, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4501317
• MDR Text Key: 5444546
• Report Number: 9680353-2015-00018
• 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: 02/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2015
• 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