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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. 16" CENTURY STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 16" CENTURY STERILIZER Back to Search Results
Device Problem Fluid Leak (1250)
Patient Problems Fall (1848); Injury (2348)
Event Date 10/24/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer and found that the manual drain valve for the steam generator required replacement. As the seal to the valve was damaged, water was able to leak from the unit. While onsite, the technician was informed that facility personnel were aware that the unit subject of the reported event was leaking and continued use of the sterilizer. The user facility did not contact steris prior to the reported event for service. User facility personnel should have immediately cleaned up the water and removed the unit from service. The century sterilizer operator manual states (1-2), "warning - slipping hazard: to prevent falls keep floors dry by immediately wiping up any spilled liquids or condensation in sterilizer loading or unloading area. " the technician replaced the manual drain valve, tested the unit, confirmed it to be operating according to specification and returned it to service. The technician counseled facility personnel on the proper use and operation of their sterilizer, specifically removing the unit from service if it is leaking. No additional issues have been reported.
 
Event Description
The user facility reported that an employee slipped and fell on water that had leaked onto the floor from their 16" century sterilizer resulting in an injury. Medical treatment was administered.
 
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Brand Name16" CENTURY STERILIZER
Type of DeviceSTERILIZER
Manufacturer (Section D)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key9372657
MDR Text Key177203890
Report Number3005899764-2019-00091
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 11/25/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/25/2019
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 Received10/24/2019
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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