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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 Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/04/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician, arrived on-site, inspected the unit, and found that the hot water supply piping and check valves required replacement. The technician identified that the check valves were damaged which allowed hot water or steam to back up within the hot water supply piping. This pressure caused the piping to overheat and fail. Steris service engineering reviewed the reported event and confirmed the technician's assessment of the issue. The technician replaced the hot water supply piping, re-built the check valves, and confirmed the unit to be operating according to specification. The sterilizer was placed back into service and no additional issues have been reported.
 
Event Description
The user facility reported the hot water supply to their 20" century sterilizer was leaking water. No injury, procedure delay, or cancellation was 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6141726
MDR Text Key61610072
Report Number3005899764-2016-00085
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 12/02/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2016
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 Received11/04/2016
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

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