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

Device Problems Fire (1245); Smoking (1585)

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

Event Date 02/07/2020

Event Type  malfunction  

Manufacturer Narrative

Contrary to the reported event, user facility personnel informed the steris service technician that arrived onsite that there was no fire and only smoke.The technician performed an inspection of the reliance vision single chamber washer and found the unit to not be operational.A replacement unit will be installed.The unit subject of this event will be returned to steris for evaluation.

Event Description

The user facility reported smoke was coming from their reliance vision single chamber washer and caught fire.No report of injury.

Manufacturer Narrative

Based on the investigation performed by steris, the c4 contactor was stuck in the closed position which allowed the drying elements to overheat and the reported event to occur.The user facility was provided with a replacement washer.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, GIC 8 A3; CA GIC 8A3
• MDR Report Key: 9800559
• MDR Text Key: 185192080
• Report Number: 9680353-2020-00008
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2020
• 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: 02/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1