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

Model Number	L500PS-03
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	10/20/2024
Type of Reportable Event	Death
Event or Problem Description
Customer stated: 2 cnas hooked up the resident in the sling to the lift.1 cna was maneuvering the lift during the transfer.The 2nd cna was guiding the resident's legs.The cnas lifted the resident and were going to move straight back and then make a 90 degree turn.When the lift was pulled straight back from the bed, the resident was adjusting herself in the sling and fell out of the sling.They think the resident fell out sideways, but they said because it happened so fast, they weren't sure.(b)(6) said all 4 loops were still on the hanger bars after the incident.
Additional Manufacturer Narrative
Did in-service with a number of staff members showed them how to move equipment smoothly, so they are not swinging people in the air.

• 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: 20687878
• Report Number: 2183887-2024-00006
• Device Sequence Number: 12893962
• 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): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Remedial Action: Inspection
• Type of Report: Initial
• Report Date (Section B): 11/14/2024

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: 10/22/2024
• Initial Report FDA Received Date: 11/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/23/2012
• 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: Life Threatening; Hospitalization; Death
• Patient Age: 84 YR
• Patient Sex: Female