MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE VISION SINGLE-CHAMBER WASHER/DISINFECTOR

Device Problem Fire (1245)

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

Event Date 08/24/2022

Event Type  malfunction  

Manufacturer Narrative

Prior to the reported event, user facility personnel stated there was a burning smell emitting from their reliance vision single chamber washer/disinfector however, the source of the burning smell could not be identified.Steris was not contacted regarding the burning smell and user facility personnel continued to utilize the washer/disinfector.A few days following the reported burning smell, the reported event occurred.A steris equipment service specialist inspected the washer/disinfector following the reported event and found evidence of charring on the chamber light and lamp socket.The components that had become damaged during the reported event had been removed by the user facility.The steris equipment service specialist discussed the reported event with user facility personnel and the contributing factors that may have caused the reported event to occur.The reliance vision single chamber washer/disinfector was installed in 2013 and is serviced and maintained by the user facility.The user facility stated that all necessary repairs and replacements will be performed by their service provider.

Event Description

The user facility reported via medwatch (mw5112000) that a small fire was observed within the chamber of their reliance vision single chamber washer/disinfector.The small fire self-extinguished when the power to the unit was turned off.No report of injury.

• Brand Name: RELIANCE VISION SINGLE-CHAMBER 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: 15463406
• MDR Text Key: 300372536
• Report Number: 9680353-2022-00025
• 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: 09/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 08/24/2022
• Initial Date FDA Received: 09/22/2022
• 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