MAUDE Adverse Event Report: STERIS CORPORATION; STERILIZER, STEAM

Model Number AMSCO 400

Device Problem Protective Measures Problem (3015)

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

Event Date 07/17/2019

Event Type  malfunction  

Event Description

Steam sterilizer #3 alarming and unable to open the door.Spoke with steris service person.It was suggested biomed cycle the autoclave off.

• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd.; mentor OH 44060
• MDR Report Key: 9320761
• MDR Text Key: 166355955
• Report Number: 9320761
• Device Sequence Number: 1
• Product Code: FLE
• 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: 10/31/2019,10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: AMSCO 400
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1