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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. AMSCO 400 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER Back to Search Results
Device Problem Device Emits Odor (1425)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/10/2017
Event Type  malfunction  
Manufacturer Narrative
The reported event did not occur during a sterilization cycle therefore no instruments were affected. A steris service technician arrived on-site, inspected the unit, and identified the smell was originating from the unit's wire harness within the power supply which had overheated; no smoke or flames were observed. The technician identified that excess conductivity gel was applied to the wire harness, causing the wire harness to short and overheat. The purpose of the gel, which is applied to the wire harness of the power supply, is to prevent corrosion of the part while still allowing for conductivity within the wire harness. The technician replaced the power supply, tested the unit, and confirmed it to be operating according to specification. The unit was returned to service. No additional issues have been reported.
 
Event Description
The user facility reported a burning smell emanating from their amsco 400 sterilizer. No injury, procedure delay, or cancellation was reported.
 
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Brand NameAMSCO 400 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 Key6396907
MDR Text Key69957786
Report Number3005899764-2017-00012
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 03/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
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 Received02/10/2017
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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