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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. 36" EAGLE STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 36" EAGLE STERILIZER Back to Search Results
Device Problems Smoking (1585); Sparking (2595)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/25/2018
Event Type  Malfunction  
Manufacturer Narrative

The fire alarm was not activated, and no evacuations were conducted. All instruments present during the time of the reported event were reprocessed prior to use. A steris service technician arrived onsite to inspect the unit and found the root cause of the reported event was the generator's heating element. As the heating element was not operating properly, this allowed the heater contactor to become stuck in the closed position subsequently causing an electrical arcing and the reported event to occur. The technician replaced the heating element and contactor, ran a test cycle, and confirmed the unit to be operating properly. The unit is under steris service agreement and no additional issues have been noted.

 
Event Description

The user facility reported the 36" eagle sterilizer's generator was emitting "sparks" and smoke. There were no injuries associated with the reported event. No report of procedure delay or cancellations.

 
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Brand Name36" EAGLE 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 Key7806899
MDR Text Key118113348
Report Number3005899764-2018-00084
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 08/22/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/22/2018
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 Received07/25/2018
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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