MAUDE Adverse Event Report: STERIS CORIPORATION. AMSCO 400 STERILIZER; STERILIZER , STEAM

Device Problem Contamination (1120)

Patient Problem No Information (3190)

Event Date 05/03/2017

Event Type  malfunction  

Event Description

The steam sterilizers have self-contained steam generators.Water supply should be ro instead feed from untreated city water.The contaminants in the water build up in the unit leading to tripping the circuit breaker with equipment shutdown.This is the third reported incident of contamination in the water effecting the sterilizers at this hospital in the past couple of months.

• Brand Name: AMSCO 400 STERILIZER
• Type of Device: STERILIZER , STEAM
• Manufacturer (Section D): STERIS CORIPORATION.; 5960 heisley rd; mentor OH 44060
• MDR Report Key: 6735725
• MDR Text Key: 80788030
• Report Number: 6735725
• Device Sequence Number: 1
• Product Code: FLE
• 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: 06/13/2017,07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/13/2017
• Device Age: 3 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/13/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1