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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 Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/27/2018
Event Type  Malfunction  
Manufacturer Narrative

The unit was installed at the customer's location in 2010 and is not under steris service agreement for maintenance activities. All maintenance activities are performed by the user facility. During the time of the reported event, user facility personnel manually activated the fire alarm due to a burning odor emitting from the sterilizer. No flames or smoke were observed; the user facility was not evacuated. Following the reported event, the user facility's biomed department inspected the sterilizer and found that the unit's heater contactor had become stuck in the closed position subsequently causing an electrical arcing and the reported event to occur. When an electrical arc occurs, heat is generated and could create a burning odor to emit from the unit. The user facility replaced the contactor, tested the unit, and confirmed it was operating properly. A steris service technician arrived onsite to inspect the sterilizer and confirmed the unit was operating according to specifications. While onsite, the technician identified the contactor subject of the event was a non-oem contactor; steris recommends only oem contactors with proper electrical ratings to be used with our sterilizers. The technician counseled user facility personnel on the importance of using oem components when performing maintenance activities. No additional issues have been reported.

 
Event Description

Reference medwatch report mw5078206. No injuries were associated with the reported event.

 
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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, 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 Key7786742
MDR Text Key117448426
Report Number3005899764-2018-00082
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 08/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/15/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
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 Received07/16/2018
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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