MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE 444 WASHER/DISINFECTOR

Device Problem Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/03/2022

Event Type  malfunction  

Event Description

The user facility reported a small amount of smoke emitted from their reliance 444 washer following a facility power outage.No report of injury.

Manufacturer Narrative

A steris service technician arrived onsite to inspect the washer and found that the washer's fuse that controls the exhaust fan had tripped due to the power outage resulting in the unit beginning to overheat and the reported event to occur.The unit has been removed from service pending repairs; a follow-up mdr will be submitted when additional information becomes available.

Manufacturer Narrative

The technician made the necessary repairs, tested the unit, confirmed it to be operating properly, and returned it to service.No additional issues have been reported.

• Brand Name: RELIANCE 444 WASHER/DISINFECTOR
• Type of Device: WASHER/DISINFECTOR
• Manufacturer (Section D): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer (Section G): STERIS CANADA ULC; 490 boulevard armand-paris; quebec, G1C 8 A3; CA G1C 8A3
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 13670854
• MDR Text Key: 286603190
• Report Number: 9680353-2022-00004
• 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,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• 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: 02/03/2022
• 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