MAUDE Adverse Event Report: STERIS CORPORATION AMSCO CENTURY STERILIZER V116; STERILIZER, STEAM

Model Number V116

Device Problem Temperature Problem (3022)

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

Event Date 01/28/2020

Event Type  malfunction  

Event Description

Flash autoclave malfunctioned because it did not reach the proper temperature.

• Brand Name: AMSCO CENTURY STERILIZER V116
• Type of Device: STERILIZER, STEAM
• Manufacturer (Section D): STERIS CORPORATION; 5960 heisley rd; mentor OH 44060
• MDR Report Key: 9652551
• MDR Text Key: 177188658
• Report Number: 9652551
• 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: 01/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: V116
• 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: 01/29/2020
• Event Location: Hospital
• Date Report to Manufacturer: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1