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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 Problems Detachment Of Device Component (1104); Component Falling (1105)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 02/13/2018
Event Type  Malfunction  
Manufacturer Narrative

During the time of the reported event, an employee was unloading a sterilizer utilizing a transfer carriage when one of the back wheels fell off subsequently causing the transfer carriage to fall to the floor. A steris service technician arrived onsite to inspect the atlas transfer carriage. The technician learned that prior to his arrival the user facility's technician adjusted and secured the transfer carriage wheel. The technician confirmed that all wheels on the transfer carriage were secure. The transfer carriage is not under a steris service agreement for maintenance activities. A steris account manager discussed with user facility personnel proper maintenance practices for their atlas transfer carriage. Steris is working with the user facility to provide replacement wheel options. No additional issues have been reported.

 
Event Description

The user facility reported that a wheel on their atlas transfer carriage fell off. No report of injury.

 
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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 Key7342412
MDR Text Key102599705
Report Number3005899764-2018-00017
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 03/15/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/15/2018
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 Received02/13/2018
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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