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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 TRASNFER CARRIAGE

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STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE TRASNFER CARRIAGE Back to Search Results
Device Problem Device Fell (4014)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/29/2019
Event Type  malfunction  
Manufacturer Narrative
A steris service technician arrived onsite following the reported event to inspect the transfer carriage and found that the front wheel assembly of the transfer carriage was unable to properly lock into place causing the transfer carriage to fall to the floor. The root cause of the reported event is attributed to a gap within the track of the transfer carriage's rails between the welded guide plates and the slot where the locking pin is inserted. The gap is wider than specification resulting in an inadequate latch causing the reported event to occur. This issue is tied to ongoing steris field correction # 1527821-10082019-001-c that was initiated on october 8, 2019. The user facility has four transfer carriages that are impacted by this correction.
 
Event Description
During an in-service training presentation, a steris account manager was operating a 66" transfer carriage when it fell to the floor. No injury.
 
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Brand Name66" EVOLUTION TRANSFER CARRIAGE
Type of DeviceTRASNFER 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 Key9376604
MDR Text Key177203412
Report Number3005899764-2019-00092
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 11/26/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/26/2019
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 Received10/31/2019
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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