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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 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" CENTURY STERILIZER Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/25/2018
Event Type  malfunction  
Manufacturer Narrative
A steris technician arrived onsite following the reported event to inspect the 20" century steam sterilizer. While onsite, the technician found that water in the sterilizer chamber did not properly drain causing residual water to remain in the chamber. When the unit was turned on, the water that was collected in the bottom of the chamber was heated, causing steam to escape through the door seal creating the reported event. The technician confirmed the root cause of this event was attributed to warn valves within the unit's draining system. The valves did not open properly to allow the water to drain, which allowed steam to build up and leak. The technician further inspected the unit's door seal and found it required replacement as steam was able to escape past the seal and into the room where the 20" century steam sterilizer is located. The technician made the appropriate repairs including replacing the door seal, ran a test cycle, and found the unit to be operating according to specification. This unit was installed in december of 2006 and is under steris service agreement. No additional issues have been reported.
 
Event Description
The user facility reported their 20" century steam sterilizer began leaking steam when the unit was turned on. No injury, procedure delay or cancellations were reported.
 
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Brand Name20" CENTURY STERILIZER
Type of DeviceSTERILIZER
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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key7720390
MDR Text Key115357435
Report Number3005899764-2018-00069
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 07/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/25/2018
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

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