MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 54" 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	03/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that while an employee was operating their evolution transfer carriage, it became unstable and fell to the floor.No report of injury.
Additional Manufacturer Narrative
A steris service technician arrived onsite to inspect the transfer carriage and found that the loading car and transfer carriage were damaged.The transfer carriage and loading car have been removed from service pending repairs.A follow-up mdr will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The technician made the necessary repairs to the loading car subject of the reported event.The loading car was tested, found to be operating according to specification, and returned to service.However, in lieu of repairing the transfer carriage, the user facility will be provided with a replacement.No additional issues have been reported.

• Brand Name: 54" 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: 14110992
• Report Number: 3005899764-2022-00013
• Device Sequence Number: 6229712
• Product Code: FLE
• UDI-Device Identifier: 00724995150358
• UDI-Public: 00724995150358
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 04/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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: 03/15/2022
• Supplement Date Received by Manufacturer: 03/15/2022; 03/15/2022
• Initial Report FDA Received Date: 04/14/2022
• Supplement Report FDA Received Date: 07/21/2022; 09/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2018
• 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