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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 Known Impact Or Consequence To Patient (2692)
Event Date 09/22/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the sterilizer. During the technician's inspection, he found that a contactor on the generator element was not operating properly. The technician found that the contactor was in the closed position causing the element to continuously heat and produce the burning odor as reported by user facility personnel. The steris service technician repaired the sterilizer, ran a test cycle and confirmed the unit to be operating properly. The sterilizer was returned to service.
 
Event Description
The user facility reported a burning odor was emitting from their sterilizer. No report of injury.
 
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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 Key6135962
MDR Text Key61234125
Report Number3005899764-2016-00084
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 11/30/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/30/2016
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 Received11/01/2016
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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