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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. 20" CENTURY STEAM STERILIZER
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STERIS MEXICO, S. DE R.L. DE C.V. 20" CENTURY STEAM STERILIZER Back to Search Results
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/19/2016
Event Type  No Answer Provided  
Manufacturer Narrative
No injury was reported and no procedural delay or cancellation was reported.A steris service technician arrived on site, inspected the unit, and found the water level control board and the pump motor contactor to not be operating properly.The technician replaced the water level control board, pump contactor, inlet water valve, and the safety valve, and confirmed the unit to be operating according to specification.
 
Event Description
The user facility reported that their century steam sterilizer was leaking water.
 
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Brand Name
20" CENTURY STEAM STERILIZER
Type of Device
STERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX  67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 67190
MX   67190
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key5510513
MDR Text Key40855511
Report Number3005899764-2016-00024
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/19/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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