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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 Problems Leak/Splash (1354); Moisture or Humidity Problem (2986)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/27/2019
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the amsco c sterilizer and found that the s9 valve required repair as the valve had disconnected from the steam manifold. As the valve was broken, steam was able to leak from the unit. The technician repaired the s9 valve, tested the unit, confirmed it to be operating according to specification, and returned it to service. A 3-year complaint review indicates this to be an isolated event. No additional issues have been reported.

 
Event Description

The user facility reported that steam was leaking overnight from their amsco c sterilizer causing water to condense on the floor. No report of injury or procedure delay.

 
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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, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8915818
MDR Text Key199549778
Report Number3005899764-2019-00075
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 08/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/21/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
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 Received07/27/2019
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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