MAUDE Adverse Event Report: EZ WAY INC 500 LB SMART LIFT WITH SCALE

Model Number	L500PS-03
Medical Device Problem Codes	Use of Device Problem (1670); Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/11/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Met with (b)(6).We went into their simulator room that had a dummie in the bed.They had the dummie hooked up to the machine with all 4 straps double looped.They said that they do not double loop and did not know why it was that way.I stressed the differences of the straps had to do with positioning.In the room they had the sling and lift that was used in the event.Lift and sling inspected - tested ok.*l500ps-03 - 140966, the machine did not have any visible issues.50578 - 162245, medium mesh sling with head support, did not see any issues with the sling- all loops were intact.Operation manual, pg 6.Step 4 - number 2.
Event or Problem Description
Resident had prior care provided by a nurse.While still in bed, the cna and cma put the sling under the resident.The cna and cma hooked up the sling to the lift and backed the lift away from the bed.The left leg strap came loose, the left leg was released and the resident fell out of the sling and hit her head on the ground.The right leg stayed in sling.

• Brand Name: 500 LB SMART LIFT WITH SCALE
• Common Device Name: LIFT
• Manufacturer (Section D): EZ WAY INC; 710 east main street; clarinda IA 51632
• Manufacturer (Section G): EZ WAY INC; 710 east main street; clarinda IA 51632
• Manufacturer Contact: amy scott ; 710 east main street; clarinda, IA 51632 ; 7125421814
• MDR Report Key: 21400531
• Report Number: 2183887-2025-00001
• Device Sequence Number: 9576298
• Product Code: FSA
• UDI-Device Identifier: 00848914000057
• UDI-Public: (01)00848914000057
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 02/17/2025

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: L500PS-03
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Death
• Patient Age: 87 YR
• Patient Sex: Female
• Patient Weight: 78 KG