• 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 Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/18/2021
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the bolt that attaches the ck5 valve to the unit was damaged allowing water to leak from the sterilizer. The technician replaced the bolt and the display assembly, tested the unit, confirmed it to be operating according to specification, and returned it to service. The amsco 400 sterilizer is not under steris service agreement for maintenance activities. The user facility is responsible for all maintenance activities. No additional issues have been reported.
 
Event Description
The user facility reported water leaking from their amsco 400 sterilizer onto the floor. 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, 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 Key13020381
MDR Text Key287273686
Report Number3005899764-2021-00061
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 12/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/16/2021
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
Date Manufacturer Received11/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/06/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-