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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 STERILIZER
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STERIS MEXICO, S. DE R.L. DE C.V. ATLAS TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER Back to Search Results
Device Problem Mechanical Problem (1384)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/15/2018
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the transfer carriage.While onsite, the technician was informed that the reported event caused the transfer carriage to fall to the floor.All instruments subject to the event were reprocessed prior to use.The technician found that the locking mechanism had become damaged causing the transfer carriage to not properly engage with the docking station subsequently allowing the transfer carriage to fall to the floor.The unit was installed at the user facility in (b)(6) 2017 and the user facility is responsible for all maintenance activities.The unit has been removed from service.The user facility has requested that steris perform the necessary repairs.Once the repairs are made, the unit will be placed back in-service.
 
Event Description
The user facility reported their atlas transfer carriage front wheels did not lock to the docking station while unloading instruments.No report of injury.
 
Manufacturer Narrative
The technician was unable to repair the locking mechanism that engages the transfer carriage to the docking station.A new transfer carriage was installed and no additional issues have been reported.
 
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Brand Name
ATLAS TRANSFER CARRIAGE
Type of Device
TRANSFER 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
MDR Report Key8254208
MDR Text Key133324043
Report Number3005899764-2019-00004
Device Sequence Number1
Product Code FLE
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/16/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Yes
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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