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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. 48" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 48" CENTURY STERILIZER Back to Search Results
Device Problem Air Leak (1008)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/14/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer. The technician inspected the sterilizer and found that the pressure reducing valve (prv) was not operating properly. When the steam emitted from the sterilizer, the steam blew onto the back of the control box subsequently causing the sterilizer to alarm an rtc failure as reported by user facility personnel. The technician rebuilt the prv, ran a test cycle and confirmed the sterilizer to be operating properly. No additional issues have been reported.
 
Event Description
The user facility reported that their sterilizer was leaking steam. No report of injury. No procedure delays or cancellations were reported.
 
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Brand Name48" 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 Key6175252
MDR Text Key62801854
Report Number3005899764-2016-00087
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 12/14/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/15/2016
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 Received11/14/2016
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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