MAUDE Adverse Event Report: STERIS CANADA ULC RELIANCE GENFORE STERILE WASHER; DISINFECTOR, MEDICAL DEVICES

Device Problem Computer Software Problem (1112)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/12/2019

Event Type  malfunction  

Event Description

The cleaning test did not pass due to a software glitch on the sterile process.This required a reset of the software.

Event Description

The cleaning test did not pass due to a software glitch on the sterile process.This required a reset of the software.

• Brand Name: RELIANCE GENFORE STERILE WASHER
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERIS CANADA ULC; 5960 heisley rd.; mentor OH 44060
• MDR Report Key: 9197093
• MDR Text Key: 162515934
• Report Number: 9197093
• 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
• Type of Report: Initial,Followup
• Report Date: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/24/2019
• Event Location: Other
• Date Report to Manufacturer: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1