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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. 66" EVOLUTION TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/30/2018
Event Type  Malfunction  
Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 66" evolution transfer carriage and found that the transfer carriage's locks were not adjusted properly. This caused the lock pin to not properly engage, making the transfer carriage unstable and allowing the loading rack to fall. If the locking pin is not at the proper height while loading and unloading, it may cause the transfer carriage to not properly engage with the docking station subsequently allowing the transfer carriage and loading rack to fall. The technician adjusted the locks correctly, tested the unit, and found it to be operating according to specification. The transfer carriage was returned to service. The evolution transfer carriage was manufactured in may 2017 and is not under steris service agreement for maintenance activities. The facility's biomed department is responsible for all maintenance activities. While onsite, the technician counseled the facility's biomed department on the proper maintenance of the evolution transfer carriage specifically, making sure the locks are adjusted properly at least once a year. No additional issues have been reported.

 
Event Description

The user facility reported that a loading rack had fallen off the 66" evolution transfer carriage. No report of injury.

 
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Brand Name66" EVOLUTION 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 Key8181093
MDR Text Key131004626
Report Number3005899764-2018-00112
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 12/19/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/19/2018
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?
Event Location No Information
Date Manufacturer Received11/30/2018
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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