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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 AMSCO 400 STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE TRANSFER CARRIAGE TO AMSCO 400 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 10/20/2016
Event Type  No Answer Provided  
Manufacturer Narrative
A steris service technician arrived at the facility following the event, inspected the transfer carriage and confirmed that the wheels had become detached from the transfer carriage base. The technician's investigation found that the root cause of the event was improper removal of the loading cart onto the transfer carriage following a sterilization cycle; specifically, failure to properly align the transfer cart to the transfer carriage upon removal. The steris technician repaired the wheels on the transfer carriage and provided in-service training to user facility personnel on proper loading and unloading techniques. No further issues have been reported.
 
Event Description
The user facility contacted steris to report the wheels had fallen off from a transfer carriage while removing a loading rack from the sterilizer. No injury was reported to user facility staff due to the reported event.
 
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Brand NameATLAS TRANSFER CARRIAGE
Type of DeviceTRANSFER CARRIAGE TO AMSCO 400 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
kathryn cadorette
5960 heisley road
mentor, OH 44060
4403927231
MDR Report Key6113019
MDR Text Key60693844
Report Number3005899764-2016-00082
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 11/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
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 Received10/20/2016
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

Patient Treatment Data
Date Received: 11/18/2016 Patient Sequence Number: 1
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