MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY SMART LIFT; EZ LIFT

Model Number L500PN

Device Problems Human-Device Interface Problem (2949); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Fall (1848); Head Injury (1879)

Event Date 12/22/2014

Event Type  Death  

Event Description

A resident was being transferred from bed to shower by 2 cnas using an ez way lift.The resident leaned and shifted her way forward causing her to fall out of the sling and onto her head from an elevated position.The resident was taken to the hospital and passed away.An ez way representative inspected the lift and sling, which were both in good condition.Facility staff recreated the scene, and the sling appeared to have been hooked up properly.The resident had previously been transferred with the ez lift multiple times per day over the past year.The lift and sling functioned properly.The incident occurred due to the resident shifting their weight and leaning forward and out of the sling.

• Brand Name: EZ WAY SMART LIFT
• Type of Device: EZ LIFT
• Manufacturer (Section D): EZ WAY, INC.; clarinda IA
• Manufacturer Contact: mary landhuis ; 807 e. main st.; clarinda, IA 51632 ; 7125425102
• MDR Report Key: 4417215
• MDR Text Key: 17579991
• Report Number: 2183887-2015-00001
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Not Applicable
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date: 01/02/2015

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
• Device Model Number: L500PN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2014
• Initial Date FDA Received: 01/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2013
• 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
• Patient Outcome(s): Death
• Patient Age: 83 YR
• Patient Weight: 102