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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Use of Device Problem (1670)
Patient Problem No Code Available (3191)
Event Date 03/23/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite to inspect the sterilizer and transfer carriage and identified there was a misalignment between the transfer carriage and sterilizer's docking station. As the latching mechanism on the front of the sterilizer was out of alignment, the employee attempted to forcefully pull the transfer carriage from the sterilizer's docking station causing the reported injury. The technician adjusted the transfer carriage to properly align with the sterilizer's docking station, tested the unit, and confirmed the equipment to be operating properly. No additional issues have been reported.

 
Event Description

The user facility reported that an employee experienced difficulty moving the transfer carriage when attempting to pull the transfer carriage away from the sterilizer causing the employee to strain their neck and shoulder. The employee sought medical treatment and returned to work.

 
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Brand NameATLAS TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO STERILIZER
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 Key7448042
MDR Text Key106848552
Report Number3005899764-2018-00026
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 04/20/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/20/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received03/23/2018
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

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