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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 Fluid/Blood Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/10/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found the fitting connecting the sterilizer to the user facility's hot water line had detached, allowing water to leak onto the floor. The technician re-installed a new fitting, tested the unit, confirmed it to be operating according to specification, and returned it to service. No additional issues have been reported.
 
Event Description
The user facility reported that overnight their amsco c sterilizer was leaking water onto the floor. No report of injury.
 
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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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8597097
MDR Text Key145033720
Report Number3005899764-2019-00047
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 05/09/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/09/2019
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 Received04/10/2019
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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