MAUDE Adverse Event Report: EZ WAY, INC. EZ WAY SMART LIFT; MOBILE LIFT

Model Number	L500PS-03
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Hematoma (1884); Liver Laceration(s) (1955)
Date of Event	08/29/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The operators instructions step 4 for the medical device used in this incident states, "1) push the up button on the hand control to initiate the upward motion of the lift boom.2) continue the upward motion until there is tension on the sling legs, making sure all the loops on the sling are securely hooked on the hanger bars." operators instructions are provided with the equipment and on the medical device manufactures web site.Site also contains videos showing the proper technique for equipment use.The facility initial reporter stated, "the lift was inspected after the incident and was found to be in excellent working condition.The sling was inspected after the incident and was found to be in good condition.The sling size was determined to be the correct size for the resident." the manufacturer believes this was user error, the user did not confirm the sling was securely hooked to the hanger bar as described in the operators instructions prior to moving the patient.
Event or Problem Description
Customer reported 2 lnas were transferring the resident from a broda chair to the bed.The lnas say the sling loops were on the lift correctly.When the resident was within an arm's length of bed, the right arm shoulder loop popped off the sling hanger.The resident fell head first, bounced off bed, and landed on the floor.
Additional Manufacturer Narrative
The operators instructions step 4 for the medical device used in this incident states, "1) push the up button on the hand control to initiate the upward motion of the lift boom.2) continue the upward motion until there is tension on the sling legs, making sure all the loops on the sling are securely hooked on the hanger bars." operators instructions are provided with the equipment and on the medical device manufactures web site.Site also contains vidoes showing the proper technique for equipment use.The facility initial reporter stated, "the lift was inspected after the incident and was found to be in excellent working condition.The sling was inspected after the incident and was found to be in good condition.The sling size was determined to be the correct size for the resident." the manufacturer believes this was user error, the user did not confirm the sling was securely hooked to the hanger bar as described in the operators instructions prioor to moving the patient.
Event or Problem Description
Customer reported 2 lnas were transferring the resident from a broda chair to the bed.The lnas say the sling loops were on the lift correctly.When the resident was within an arm's length of bed, the right arm shoulder loop popped off the sling hanger.The resident fell head first, bounced off bed, and landed on the floor.

• Brand Name: EZ WAY SMART LIFT
• Common Device Name: MOBILE 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: aaron davidshofer ; 710 east main street; clarinda, IA 51632 ; 7125421939
• MDR Report Key: 17953926
• Report Number: 2183887-2023-00005
• Device Sequence Number: 12680107
• Product Code: FSA
• UDI-Device Identifier: 00848914000057
• UDI-Public: (01)00848914000057
• Combination Product (Y/N): N
• Initial Reporter State: NH
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

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: Not provided
• Supplement Date Received by Manufacturer: 09/13/2023
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 72 KG