• 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 600 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 600 STERILIZER Back to Search Results
Model Number AMSCO 600 Steam Sterilizer
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/01/2021
Event Type  malfunction  
Event Description
The user facility reported water was leaking from their amsco 600 sterilizer onto the floor. No report of injury.
 
Manufacturer Narrative
A steris service technician arrived onsite to inspect the unit and found that the flexible hose that connects the facility cold water piping to the unit's piping was damaged causing water to leak onto the floor. The technician made the necessary repairs, tested the unit, confirmed it to be operating according to specification, and returned it to service. The hose subject of the reported event will be returned for evaluation. A follow-up mdr will be submitted when additional information becomes available.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameAMSCO 600 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 Key12715540
MDR Text Key281410606
Report Number3005899764-2021-00056
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,Followup
Report Date 10/28/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAMSCO 600 Steam Sterilizer
Device Catalogue NumberEF1201142
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/01/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-