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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 Collapse (1099)
Patient Problem Injury (2348)
Event Date 06/05/2018
Event Type  Malfunction  
Manufacturer Narrative

The user facility declined to provide further information on details of the event. A steris service technician arrived onsite following the reported event. While inspecting the unit, the technician noted the cart shelves were bent towards the middle of the shelf, the jam nuts on the crank handle assembly were not properly adjusted, and the elevator assembly was incorrectly positioned. The transfer cart has been in service since 1/26/2017 and is not under steris maintenance contract. To resolve the issue, the technician properly adjusted the jam nuts on the crank handle and repositioned the elevator assembly. The technician tested the unit, found it to be operating according to specifications and returned it to service. The reported event can be attributed to improper maintenance of the unit, resulting in difficulty to properly maneuver the racks and cart.

 
Event Description

The user facility reported that while loading their atlas transfer carriage into a sterilizer, a rack collapsed, resulting in an employee injury. Medical treatment was sought.

 
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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 Key7659898
MDR Text Key113289419
Report Number3005899764-2018-00055
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 07/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/03/2018
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? No
Event Location No Information
Date Manufacturer Received06/05/2018
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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