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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO CENTURY STEAM STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. AMSCO CENTURY STEAM STERILIZER Back to Search Results
Model Number CENTURY
Device Problem Mechanical Problem (1384)
Patient Problem No Information (3190)
Event Date 02/12/2018
Event Type  malfunction  
Event Description
The amsco century autoclave units that we have here are cleaned on a weekly basis as indicated in the ifu's (instructions for use). According to the ifu's, the fluids used in the cleaning of the autoclave chamber will drain out of the chamber over a short period of time following the cleaning process. Following the cleaning process the fluid in the chamber does not drain, even over a long period of time. The autoclave units are powered back up with the fluid in the chamber creating a faint water line to burn onto the chamber surface. Manufacturer response for autoclave, amsco (per site reporter). The ifu's are written for multiple model types and there may be variations from model type to model type.
 
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Brand NameAMSCO CENTURY
Type of DeviceSTEAM STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
5960 heisley rd.
mentor OH 44060
MDR Report Key9191120
MDR Text Key162849067
Report Number9191120
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 09/24/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/15/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberCENTURY
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/24/2019
Device Age10 YR
Event Location Hospital
Date Report to Manufacturer10/09/2019
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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