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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

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STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Burn, Thermal (2530)
Event Date 11/21/2019
Event Type  malfunction  
Manufacturer Narrative
During the time of the reported event, the employee was removing the loading car with liquid bottles from the sterilizer when one of the transfer carriage's wheels detached allowing the transfer carriage and loading car to fall to the floor. As the loading car fell the bottles spilled out onto the floor causing them to break and for hot liquid to make contact with the employee's foot. A steris service technician arrived onsite to inspect the unit and found that the bolt that secures the wheel in place had become loose subsequently allowing the wheel to detach. The technician ordered a replacement wheel assembly, replaced the wheel, tested the unit, confirmed it to be operating according to specification, and returned it to service. The unit was manufactured in 2007 and is approximately 12 years old. The transfer carriage and loading car are not under a steris service agreement for maintenance activities. The user facility is responsible for all maintenance activities. Based on the technician's inspection, the root cause of the reported event can be attributed to improper maintenance of the unit. The atlas transfer carriage preventive maintenance checklist states (pg. 1, section 3), "perform annually- check floor casters for wear and tighten caster assembly. Note: any worn rubber expander assemblies should be replaced with the wedge block assemblies. " while onsite, the technician counseled user facility personnel on the importance of properly maintaining the unit. No additional issues have been reported.
 
Event Description
The user facility reported that an employee obtained a burn on their foot while removing a load from the sterilizer with an atlas transfer carriage. No medical treatment was administered.
 
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Brand NameATLAS 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 Key9496051
MDR Text Key199552490
Report Number3005899764-2019-00097
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 12/19/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2019
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 Received11/21/2019
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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