MAUDE Adverse Event Report: STERIS CORPORATION RELIANCE 444; DISINFECTOR, MEDICAL DEVICES

Model Number 444

Device Problem Difficult to Open or Close (2921)

Patient Problem No Patient Involvement (2645)

Event Date 05/21/2018

Event Type  malfunction  

Event Description

Sterile processing preparing to sterilize instruments; door to washer would not open.Manufacturer response for decontaminate washer, amsco (per site reporter).Steris came out to the facility and repaired the door.

• Brand Name: RELIANCE 444
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• MDR Report Key: 7955823
• MDR Text Key: 123419228
• Report Number: 7955823
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 444
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/27/2018
• Event Location: Hospital
• Date Report to Manufacturer: 10/11/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1