• 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. 54" 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. 54" EVOLUTION TRANSFER CARRIAGE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Pain (1994)
Event Date 10/07/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the 54" transfer carriage. The technician inspected the unit and found that the transfer carriage was not level. This caused the loading car to drag on the guide rails making it difficult to move the car in and out of the sterilizer and the reported event to occur. While onsite, the technician adjusted the transfer carriage, tested the unit, and found it to be operating according to specification. The transfer carriage was returned to service. No additional issues have been reported.
 
Event Description
The user facility reported an employee obtained a sore back while operating their 54" transfer carriage. Medical treatment was sought and administered. The employee returned to work the next day.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name54" 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, 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 Key9286890
MDR Text Key199551546
Report Number3005899764-2019-00086
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 11/06/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/06/2019
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 Received10/07/2019
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

-
-