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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. 42" EVOLUTION STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 42" EVOLUTION STERILIZER Back to Search Results
Device Problem Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/09/2016
Event Type  No Answer Provided  
Manufacturer Narrative

A steris service technician visited the facility following the event and found the facility has 3 units, including the evolution sterilizer, which connect to the floor drain. The standing water is attributed to an inadequate floor drain which could not accommodate the multiple units. The user facility has been made aware of their drain issues and is in the process of installing a new drain to meet the requirements of all three units. Steris was additionally informed that an employee received a "static shock" while standing in the puddle of water and touching a piece of equipment in the room. The employee did not seek medical treatment and resumed normal work duties. While onsite, the steris technician confirmed the steris evolution sterilizer was correctly grounded and was operating according to specification. The customer believes the employee subject of the report event received a shock from normal static electricity and not from an electrical issue with the sterilizers.

 
Event Description

The user facility reported standing water was discovered near the facility's floor drain, which connects to the evolution sterilizer.

 
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Brand Name42" EVOLUTION 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 Key5489417
MDR Text Key39981102
Report Number3005899764-2016-00018
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 03/09/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received02/09/2016
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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