MAUDE Adverse Event Report: STERIS MEXICO, S. DE R.L. DE C.V. 60" ATLAS TRANSFER CARRIAGE; TRANSFER CARRIAGE TO STERILIZER

Device Problem Device Tipped Over (2589)

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

Event Date 08/03/2016

Event Type  No Answer Provided  

Manufacturer Narrative

A steris service technician arrived on-site, inspected the unit, and identified the caster was damaged; specifically, the rubber gasket used to lock the caster in place was identified to be worn.The technician replaced the 4 casters on the cart, tested the unit, and confirmed the unit to be operating according to specification.The technician identified that the reported event was due to improper maintenance of the casters.The unit was manufactured in 2005 and was not under steris contract for preventative maintenance services at the time of the reported event.As a result of the reported event, the user facility has decided to contract steris for future maintenance services.No additional issues have been noted.

Event Description

The user facility reported that a user facility employee was moving a fully loaded transfer cart when a caster detached from the cart causing the cart to tip over.No injury, procedural delay, or cancellation was reported.

• Brand Name: 60" 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
• 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: kathryn cadorette ; 5960 heisley road; mentor, OH 44060 ; 4403927231
• MDR Report Key: 5919176
• MDR Text Key: 54327536
• Report Number: 3005899764-2016-00060
• 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: 08/31/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2016
• Initial Date FDA Received: 08/31/2016
• 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