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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" MILLENNIUM STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" MILLENNIUM STERILIZER Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 20" millennium sterilizer. While onsite, the technician was able to identify the root cause of the steam leak to originate from the unit's pressure relief valve (prv). As designed, this valve opened when the unit detected an excess of pressure inside the sterilizer chamber, thus releasing steam. The technician readjusted the high/low pressure switch and prv, ran a test cycle, and found the unit to be operating according to specification. This unit was installed in (b)(6) 2002 and is under steris service agreement. No additional issues have been reported.
 
Event Description
The user facility reported a steam leak from their 20" millennium sterilizer. No injury, procedure delay, or cancellation was reported.
 
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Brand Name20" MILLENNIUM 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 Key7724315
MDR Text Key115368621
Report Number3005899764-2018-00070
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 07/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/26/2018
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 Received06/26/2018
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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