MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 220 CART WASHER

Device Problems Fluid/Blood Leak (1250); Device Displays Incorrect Message (2591)

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

Event Date 03/17/2015

Event Type  No Answer Provided  

Event Description

The user facility reported their reliance 220 cart washer was emitting steam from around the doors during a cycle.The fire alarm was triggered due to the reported event, but no evacuations occurred.No report of injury or procedural delay or cancellation.The fire department was not dispatched to the user facility.

Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified the drying fan's belts required replacement.Due to the damaged belt on the drying fan, the fan was not able to clear the steam and condense it from within the cart washer effectively and thus caused the reported event.The technician replaced the drying fan belt.He tested the unit, ensured the steam cleared properly, and confirmed it to be operating according to specification.This unit is not under steris contract agreement for maintenance.

• Brand Name: RELIANCE 220 CART WASHER
• 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: 4694944
• MDR Text Key: 19986883
• Report Number: 9680353-2015-00030
• Device Sequence Number: 1
• Product Code: FLH
• 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: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2015
• 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: 03/17/2015
• 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