MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 66" EVOLUTION TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

Device Problem Device Fell (4014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/30/2018

Event Type  malfunction  

Manufacturer Narrative

A steris service technician arrived onsite following the reported event to inspect the 66" evolution transfer carriage and found that the transfer carriage's locks were not adjusted properly.This caused the lock pin to not properly engage, making the transfer carriage unstable and allowing the loading rack to fall.If the locking pin is not at the proper height while loading and unloading, it may cause the transfer carriage to not properly engage with the docking station subsequently allowing the transfer carriage and loading rack to fall.The technician adjusted the locks correctly, tested the unit, and found it to be operating according to specification.The transfer carriage was returned to service.The evolution transfer carriage was manufactured in may 2017 and is not under steris service agreement for maintenance activities.The facility's biomed department is responsible for all maintenance activities.While onsite, the technician counseled the facility's biomed department on the proper maintenance of the evolution transfer carriage specifically, making sure the locks are adjusted properly at least once a year.No additional issues have been reported.

Event Description

The user facility reported that a loading rack had fallen off the 66" evolution transfer carriage.No report of injury.

• Brand Name: 66" EVOLUTION 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
• Manufacturer (Section G): STERIS MEXICO, S. DE R.L. DE C.V.; avenida avante 790; parque industrial guadalupe; guadalupe, nuevo leon 67190 ; MX 67190
• Manufacturer Contact: daniel davy ; 5960 heisley road; mentor, OH 44060 ; 4403927453
• MDR Report Key: 8181093
• MDR Text Key: 131004626
• Report Number: 3005899764-2018-00112
• Device Sequence Number: 1
• Product Code: FLE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/30/2018
• 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
• Patient Sequence Number: 1