MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY SMART LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number L500PS

Device Problems Break (1069); Mechanical Problem (1384); Device Markings/Labelling Problem (2911); Fail-Safe Problem (2936)

Patient Problem Fall (1848)

Event Date 06/20/2023

Event Type  Injury  

Event Description

Ez way smart lift rated for 500 lbs.Failed when the actuator gave out while the lift was engaged to lift the resident.Resident fell to the floor, falling approximately 4 feet.No major injury determined from the fall.

• Brand Name: EZ WAY SMART LIFT
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): EZ WAY, INC.; clarinda IA 51632
• MDR Report Key: 17240080
• MDR Text Key: 318289558
• Report Number: MW5119032
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: L500PS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White