MAUDE Adverse Event Report: STERIS CANADA CORPORATION RELIANCE 444 WASHER

Device Problem Fumes or Vapors (2529)

Patient Problem Irritation (1941)

Event Date 04/11/2019

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance 444 washer and found that the transformer had blown a fuse and started to melt subsequently causing the reported event to occur.The technician replaced the transformer, tested the unit, confirmed it to be operating according to specification, and returned it to service.The unit was installed in 2008 making it approximately 11 years old.A 3-year complaint review indicates this to be an isolated event.No additional issues have been reported.

Event Description

The user facility reported that their reliance 444 washer was emitting a burning smell.The user facility immediately shut off power to the unit.One employee reported eye irritation.A procedure delay was reported.No report of smoke or fire.

• Brand Name: RELIANCE 444 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: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8597096
• MDR Text Key: 144863571
• Report Number: 9680353-2019-00016
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• 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: 04/11/2019
• 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