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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Abrasion (1689)

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite to inspect the reliance 444 washer/disinfector and found that the door security sensors were not operating properly and required replacement.The unit is approximately 23 years old and is not under steris service agreement for maintenance activities.The user facility is responsible for all maintenance activities.The reliance 444 washer/disinfector operator manual states (1-1), "regularly scheduled preventive maintenance is required for safe and reliable operation of this equipment." the technician replaced the door security sensors, tested the unit, confirmed it was operating according to specification, and returned the unit to service.A steris account manager offered in-service training on the proper use and operation of their reliance 444 washer/disinfector, specifically to ensure sensors are operating properly during preventive maintenance; however, steris is pending a response from the user facility.A follow-up mdr will be submitted when additional information becomes available.

Event Description

The user facility reported an employee obtained an injury to their finger while attempting to unload their reliance 444 washer/disinfector.Medical treatment was sought; however, user facility personnel did not disclose if medical treatment was administered.

Manufacturer Narrative

A steris account manager offered in-service training on the proper use and operation of their reliance 444 washer/disinfector, specifically to ensure sensors are operating properly during preventive maintenance; however, the user facility declined.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: 12857950
• MDR Text Key: 285686047
• Report Number: 9680353-2021-00045
• 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: 11/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2021
• 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