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

Device Problems Component Falling (1105); Mechanical Problem (1384)

Patient Problem Injury (2348)

Event Date 10/29/2015

Event Type  No Answer Provided  

Manufacturer Narrative

The reported event occurred due to the user facility's floor drain.The drain has a cover which was not secured down with screws.When the weight of the transfer cart passed over the drain, the cover shifted and allowed for the wheel to fall into the drain.A steris field service technician arrived onsite, inspected the transfer cart, and identified a wheel had sustained damage from the reported fall.The technician replaced the wheel, tested the unit, and confirmed it to be operating according to specification.

Event Description

The user facility reported that an employee obtained an arm injury after their 66" evolution transfer cart's wheel became caught in the user facility's floor drain subsequently causing the cart to tip and fall.The employee attempted to prevent the cart from falling and incurred the reported arm injury.It is unknown if medical treatment was sought or administered.

• Brand Name: TRANSFER CART TO 66" EVOLUTION STERILIZER
• Type of Device: 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: 5237809
• MDR Text Key: 31672746
• Report Number: 3005899764-2015-00079
• 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: 11/19/2015

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/29/2015
• Initial Date FDA Received: 11/19/2015
• 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