MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. EVOLUTION TRANSFER CARRIAGE

Model Number	AX082020003
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A steris service technician inspected the 54" transfer carriage and found the locking pins to be misaligned.As the locking pins were misaligned, the loading cart was not locked to the transfer carriage subsequently causing the reported event to occur.The 54" transfer carriage is not under a steris service contract and is serviced and maintained by the user facility.While the steris service technician was on-site, he counseled user facility personnel on the proper use and operation of the transfer carriage.The 54" transfer carriage remains out of service and is pending repairs.A follow-up report will be submitted once additional information becomes available.
Event or Problem Description
The user facility reported via medwatch (mw5111744) that while an employee was utilizing their 54" transfer carriage, the loading cart tipped forward and fell to the floor.No report of injury.
Additional Manufacturer Narrative
In lieu of repairing the transfer carriage subject of the reported event, the user facility purchased a new transfer carriage.

• Brand Name: EVOLUTION TRANSFER CARRIAGE
• Common Device Name: TRANSFER 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 Key: 15473760
• Report Number: 3005899764-2022-00048
• Device Sequence Number: 4323040
• Product Code: FLE
• UDI-Device Identifier: 00724995150358
• UDI-Public: 00724995150358
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AX082020003
• Device Catalogue Number: AX082020003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 10/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/30/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown