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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 Injury (2348)
Event Date 04/22/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the atlas transfer carriage and found no issue with the function or operation of the carriage. No repairs were required and the carriage was returned to service. Through follow-up with facility personnel, the technician learned that facility personnel had not ensured that the loading car was properly engaged with the transfer carriage when unloading instruments from a previous cycle. As facility personnel subsequently utilized this loading car and transfer carriage to load instruments, the loading car slid off the transfer carriage and into the sterilizer. The employee attempted to move the loading car and subsequently hit the right side of their body on the transfer carriage causing the reported event to occur. The reported event is attributed to user error. The atlas transfer carriage operator manual states (1), "warning - prevent physical injury: always positively latch loading car to transfer carriage when car is outside sterilizer. " the operator manual further states, "warning - prevent physical injury: get help if loading car becomes stuck or difficult to move. Do not attempt to lift a loading car without assistance. " the technician counseled user facility personnel on proper use and operation of the atlas transfer carriage. No additional issues have been reported.
 
Event Description
The user facility reported that an employee was injured while operating their atlas transfer carriage. Medical treatment was sought. Facility personnel did not disclose if 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 Key8634071
MDR Text Key145934414
Report Number3005899764-2019-00053
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 05/22/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
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 Received04/22/2019
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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