• 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. 66" EVOLUTION TRANSFER CARRIAGE

  • 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. 66" EVOLUTION TRANSFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/20/2019
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the transfer carriage following the reported event. The technician was informed that after an employee loaded instruments into the sterilizer, the transfer carriage's front wheels were not fully locked into the sterilizer docking station; causing the front of the transfer carriage to fall to the floor. The instrument packs were not affected as they were loaded into the sterilizer prior to the subject event. The technician inspected the transfer carriage and loading car and was unable duplicate the reported event; no repairs were required. The reported event can be attributed to user error as the employee did not fully engage the transfer carriage to the sterilizer's docking station. While onsite, the technician counseled user facility personnel on the proper procedure for loading and unloading the sterilizer. No additional issues were reported.

 
Event Description

The user facility reported that after loading the sterilizer their 66" evolution transfer carriage fell to the floor. No injuries were associated with the reported event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name66" EVOLUTION TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE
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 Key8527287
MDR Text Key142532376
Report Number3005899764-2019-00040
Device Sequence Number1
Product Code FLE
Combination Product (Y/N)N
Reporter Country CodeCA
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 04/18/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/18/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
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 Received03/20/2019
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

-
-