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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS CORPORATION STERILIZER, STEAM

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STERIS CORPORATION STERILIZER, STEAM Back to Search Results
Model Number AMSCO 400
Device Problems Device Alarm System (1012); Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/14/2019
Event Type  Malfunction  
Event Description

Autoclave #3 alarming with front screen showing board failure. Biomed notified. Biomed determined there was a steam leak in the device.

 
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Type of DeviceSTERILIZER, STEAM
Manufacturer (Section D)
STERIS CORPORATION
5960 heisley rd.
mentor OH 44060
MDR Report Key9320740
MDR Text Key166355525
Report Number9320740
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Number of Events Reported1
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
0 PatientS WERE Involved in the Event:
Date FDA Received11/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberAMSCO 400
Was Device Available For Evaluation? No Answer Provided
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA10/31/2019
Event Location Hospital
Date Report TO Manufacturer11/14/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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