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

Model Number	L500PS-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Multiple Fractures (4519)
Date of Event	03/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Resident has a specialty wheel chair.The lift was on patient's left side, and the bed was on her right side.The cnas hooked up the resident with top loops on red and bottom/leg loops on silver.Cnas started lifting resident.Her feet were straight out.They cleared the chair and paused to get resident's weight.They started to pull back.One cna was guiding the resident and the 2 cna was guiding the legs.The top left shoulder loop came off and resident fell.The cnas tried to break the fall.Resident was parallel to wheelchair and fell on floor.The resident sustained a left 2nd and 3rd rib fracture.

• 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: 24966967
• Report Number: 2183887-2026-00005
• Device Sequence Number: 21456633
• Product Code: FSA
• UDI-Device Identifier: 00848914000057
• UDI-Public: (01)00848914000057
• 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
• Type of Report: Initial
• Report Date (Section B): 04/23/2026

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: L500PS-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: 03/16/2026
• Initial Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/28/2025
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Hospitalization; Required Intervention
• Patient Age: 84 YR
• Patient Sex: Female
• Patient Weight: 89 KG