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

Device Problem Difficult to Open or Close (2921)

Patient Problem No Information (3190)

Event Date 10/20/2015

Event Type  malfunction  

Event Description

The doors on the instrument washer would not open.

• Brand Name: RELIANCE SYNERGY
• Type of Device: DISINFECTOR, MEDICAL DEVICES
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley road; mentor OH 44060
• MDR Report Key: 5182979
• MDR Text Key: 29748982
• Report Number: 5182979
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/21/2015
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/21/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1