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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. 60" ATLAS TRANSFER CARRIAGE

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STERIS MEXICO, S. DE R.L. DE C.V. 60" ATLAS TRANSFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/19/2019
Event Type  Malfunction  
Manufacturer Narrative

All instruments subject of the reported event were reprocessed prior to use. A steris service technician arrived onsite following the reported event to inspect the transfer carriage however, the facility was unable to identify which unit had the issue. The facility has multiple transfer carriages, and the facility's biomed department had fixed the wheel before the technicians arrival. The technician inspected all six units and found that several wheels on the transfer carriages were loose. The technician tightened the wheels, tested each transfer carriage, and found all units to be operating according to specification. The transfer carriages are not under contract for steris maintenance activities. The user facilities biomed department is responsible for all maintenance activities. The root cause of the reported event can be attributed to improper maintenance of the transfer carriages. While onsite the technician counseled the facility's biomed department on the proper use and maintenance of the transfer carriage specifically, properly tightening the wheels on the transfer carriages. No additional issues have been reported.

 
Event Description

The user facility reported that as an employee was removing a processed load from the sterilizer, a wheel fell off the 60" atlas transfer carriage causing the loading car and instruments to fall to the floor. No report of injury.

 
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Brand Name60" ATLAS 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 Key8524537
MDR Text Key142507412
Report Number3005899764-2019-00037
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 04/17/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/17/2019
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?
Event Location No Information
Date Manufacturer Received03/19/2019
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

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