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

Device Problems Device Emits Odor (1425); Smoking (1585)

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

Event Date 06/04/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their reliance synergy washer/disinfector emitted a burning smell and smoke.No report of injury or procedural delay or cancellation.No evacuations were required.

Manufacturer Narrative

The fire alarm sounded and the fire department was dispatched to the user facility.All instruments were reprocessed.A steris field service technician arrived onsite and inspected the unit, and identified the over-temperature switch (ots) tripped but the contactor (ch2) stuck in a closed/energized position.The closed contactor allowed for the recirculation pump to continuously run.The water then drained from the washer during the cycle and the pump ran dry and causing excessive friction and heat.There are no combustible materials present in the reliance synergy washer/disinfector.Materials located in the bottom of the unit include stainless steel, high temperature rated wiring, ul & csa approved plastic, and fiber glass insulation.The technician replaced the recirculation pump and contactor, tested the unit, and confirmed it to be operating according to specification.No additional issues have been reported.

• Brand Name: RELIANCE SYNERGY WASHER/DISINFECTOR
• Type of Device: WASHER
• Manufacturer (Section D): STERIS CANADA CORPORATION; 490 armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer (Section G): STERIS CANADA CORPORATION; 490, armand-paris; quebec, quebec GIC 8A3; CA GIC 8A3
• Manufacturer Contact: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 4861708
• MDR Text Key: 5813128
• Report Number: 9680353-2015-00039
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2015
• 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: 06/04/2015
• 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