• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

STERIS MEXICO, S. DE R.L. DE C.V. AMSCO 400 STERILIZER Back to Search Results
Device Problem Gas Leak (2946)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/02/2019
Event Type  malfunction  
Manufacturer Narrative
All instruments subject of the reported event were reprocessed prior to use. A steris service technician arrived onsite following the reported event to inspect the amsco 400 sterilizer. The technician inspected the unit and found the root cause of the reported event to be the unit's safety valve. The safety valve had failed, allowing access steam to leak out. Based on the condition of the safety valve, it does not appear that biomed department had been checking the safety valve as required during pm inspections. The technician replaced the safety valve, ran a test cycle, and found the unit to be operating according to specification. The unit was returned to service. The amsco 400 sterilizer was installed in 2014 and is not under steris service agreement for maintenance activities. The facilities biomed department is responsible for maintenance activities. No additional issues have been reported.
 
Event Description
The user facility reported steam was leaking from their amsco 400 sterilizer resulting in a procedure delay. No report of injury.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key8457508
MDR Text Key140144882
Report Number3005899764-2019-00028
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 03/27/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/27/2019
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 Received03/04/2019
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

-
-