MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE; DISINFECTOR, MEDICAL DEVICES

Model Number 1227

Device Problem Defective Component (2292)

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

Event Date 12/01/2021

Event Type  malfunction  

Event Description

Reliance® 1227 cart and utensil washer/disinfector displayed alarm #7, recirculation error, on the screen for staff, health technology management responded and worked with steris to resolve the issue.Over the course of three months, the replacement of all parts of the system affected, multiple visits from steris, it was determined to be a door sensor that failed.The general nature of the error with no way of seeing what generated it in the system from either the hospital or steris technicians resulted in excessive cost of repair and an unreasonable down time for this device.

• Brand Name: RELIANCE
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERIS CORPORATION; 5960 heilsey road; mentor OH 44060
• MDR Report Key: 15635740
• MDR Text Key: 302067318
• Report Number: 15635740
• Device Sequence Number: 1
• Product Code: MEC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/28/2022,09/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 1227
• Device Catalogue Number: FW03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2022
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1