MAUDE Adverse Event Report: EZ WAY INC 600 LB SMART LIFT W/SCALE

Model Number	L600PS-03
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Head Injury (1879); Multiple Fractures (4519)
Date of Event	04/29/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sling that was used during the incident went with the client to the hospital and now cannot be found.
Event or Problem Description
Transferring resident from wheelchair to bed.Resident was up in air off of chair.The cnas pulled the chair out from under resident and were getting ready to turn.They heard a snap sound and the resident fell to the floor.The resident's right side was out of sling and resident hit head on floor.Resident had broken a femur, broken collar bone, and broken neck.The resident had a subdural hematoma.

• Brand Name: 600 LB SMART LIFT W/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: 25116643
• Report Number: 2183887-2026-00006
• Device Sequence Number: 10232112
• Product Code: FSA
• UDI-Device Identifier: 00848914000019
• UDI-Public: (01)00848914000019
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/07/2026

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: L600PS-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: 05/01/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2019
• 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: Required Intervention; Hospitalization
• Patient Sex: Female
• Patient Weight: 146 KG