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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 C STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. AMSCO C STERILIZER Back to Search Results
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/07/2016
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 identified that the contactor was stuck in a closed position causing the integral steam generator on the unit to continue running. As the steam generator continued to run, steam and water was released from the unit's safety valve. The steris service technician replaced the contactor, steam generator, and safety valve; ran a test cycle; and confirmed the unit to be operating properly. The sterilizer was returned to service.
 
Event Description
The user facility reported that steam and water was leaking from their amsco c sterilizer. No injury, procedure delay, or cancellation was reported.
 
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Brand NameAMSCO C 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 Key6153014
MDR Text Key62222036
Report Number3005899764-2016-00086
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 12/07/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
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 Received11/07/2016
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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