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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. 42" EVOLUTION TRANSFER CARRIAGE

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STERIS MEXICO, S. DE R.L. DE C.V. 42" EVOLUTION TRANSFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem Injury (2348)
Event Date 08/21/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite to inspect the to inspect the carriage and found the locking mechanism had evidence of rusting and required lubrication. While onsite, the technician spoke with user facility personnel who stated that they had been washing the transfer carriage in a cart washer. User facility personnel should not wash their transfer carriages with a cart washer as this does not align with steris' recommended cleaning practices. The reported event is attributed to user error as facility personnel had not been following proper cleaning practices. The cart washer removed the lubrication from the carriage and caused the rusting. The evolution transfer carriage operator manual (5-1) states, "clean evolution transfer carriage as follows: using a lint free cloth, wash transfer carriage with a mild detergent solution. " the transfer carriage was removed from service. The technician counseled facility personnel on the proper use and operation of their evolution transfer carriage, specifically proper cleaning practices. No additional issues have been reported.
 
Event Description
The user facility reported that a loading car fell on an employee's leg while operating their 42" evolution transfer carriage. The employee sought medical treatment; no medical treatment was administered. All instruments were reprocessed prior to use.
 
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Brand Name42" EVOLUTION 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, 67190
MX 67190
Manufacturer (Section G)
STERIS MEXICO, S. DE R.L. DE C.V.
avenida avante 790
parque industrial guadalupe
guadalupe, 67190
MX 67190
Manufacturer Contact
daniel davy
5960 heisley road
mentor, OH 44060
4403927453
MDR Report Key9099944
MDR Text Key199550131
Report Number3005899764-2019-00080
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 09/20/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/20/2019
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 Received08/22/2019
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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