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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. 20" AMSCO 400 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 20" AMSCO 400 STERILIZER Back to Search Results
Device Problems Moisture or Humidity Problem (2986); Noise, Audible (3273)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/28/2015
Event Type  No Answer Provided  
Event Description

The user facility reported their unit was making noise and emitting steam. No report of injury.

 
Manufacturer Narrative

A steris field service technician arrived onsite, inspected the unit, and identified the steam originated from the steam generator. The technician noted the system was over-pressurized but was unable to determine what caused this condition. It is likely the pressure relief valve sensed pressure buildup in the chamber and released pressure as it approached top-rated pressure levels (80 psig). Page 141 of the operator manual states that chamber pressure/temperature failure may, "[occur] if chamber pressure or temperature readings are outside the normal steam range during sterilize phase. " the technician replaced the hi-limit pressure switch and operating controls and the generator safety valve, tested the unit, and confirmed it to be operating according to specification.

 
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Brand Name20" AMSCO 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 6719 0
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, nuevo leon 6719 0
MX 67190
Manufacturer Contact
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key4546367
MDR Text Key15965806
Report Number3005899764-2015-00011
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 02/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/25/2015
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
Date Manufacturer Received01/28/2015
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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