MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE VISION SINGLE CHAMBER WASHER

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the washer.The technician ran a test cycle and observed the washer alarmed "alarm 28: pump pressure not detected".This alarm occurred with user facility personnel which subsequently dispatched the steris service technician to inspect the unit.The technician reset the cb1 breaker and ran another test cycle.During the drying phase of the test cycle, the c4 contactor got stuck in the closed position.The c4 contactor being stuck in the closed position allowed a continuous electrical current to feed, and eventually overheat, the unit's heating elements.Failure of the contactor to move from a closed to an open position is indicative of a mechanical failure of the component caused by arching inside of the washer sufficient to weld the contactor into the closed position.The washer was removed from service and is pending repairs.A follow-up report will be submitted once repairs are completed.

Event Description

The user facility reported that their reliance vision single chamber washer was not operating properly.No report of injury, procedure delays or cancellations.

Manufacturer Narrative

The steris service technician repaired the washer, ran a test cycle and confirmed the unit to be operating properly.The washer was returned to service and no additional issues have been reported.

• Brand Name: RELIANCE VISION SINGLE CHAMBER WASHER
• 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: lyndsey snyder ; 5960 heisley road; mentor, OH 44060 ; 4403927386
• MDR Report Key: 6814508
• MDR Text Key: 83622609
• Report Number: 9680353-2017-00060
• 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,Followup
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/24/2017
• 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