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

Model Number	L500PN-03
Medical Device Problem Codes	Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	Fall (1848)
Date of Event	05/03/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
The family had a camera to record interactions with the resident and recorded this incident.
Event or Problem Description
Cna was on each side of bed, hooking up straps to the lift.The cna on the side of the bed with the machine hooked up a loop to the lift and moved to the other side of the bed.While moving to the other side, the cna was picking things up and moving things and one of the leg loops did not get hooked up to the machine.When the resident was lifted off the bed, she slid out of the sling.The resident died the next day.(b)(6) said the lift was not at fault and this was user error.

• Brand Name: 500 LB SMART LIFT
• 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: 25173528
• Report Number: 2183887-2026-00007
• Device Sequence Number: 10181879
• Product Code: FSA
• UDI-Device Identifier: 00848914000040
• UDI-Public: (01)00848914000040
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 05/14/2026

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: L500PN-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/14/2026
• 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 Sex: Female
• Patient Weight: 52 KG