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

Model Number	L600PS-03
Medical Device Problem Codes	Labelling, Instructions for Use or Training Problem (1318); Use of Device Problem (1670); Premature Separation (4045)
Health Effect - Clinical Code	Limb Fracture (4518)
Date of Event	10/20/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
2 caregivers transferring resident from bed to chair and resident fell.Carissa said one of the harness straps came off the stand.The resident fell and had a fractured femur.
Additional Manufacturer Narrative
Multiple attempts made to investigate this incident and gather additional information.They went to the hospital and came back to the nursing home.Arrived at facility, met brandon(maintenance director in the foyer area.We went to conference room to meet with assistant director of nursing and unit nurse.We discussed the incident the was on (b)(6) 2023.Brandon advised that he checked the unit right after the incident.He said the unit was in proper working condition.All 3 said it was not the unit(lift), it was operator error.There were 2 caregivers when the incident occurred.They are no longer at this facility.The incident happened doing a transfer from the bed to chair.Asked about the residents health, they mentioned she has multiple preexisting conditions.There were no medical codes noted.We also discussed future inservices.Left card and catalog.We will follow up in 2 weeks.

• Brand Name: 600 LB SMART LIFT WITH SCALE
• Common Device Name: LIFT
• Manufacturer (Section D): EZ WAY INC; 710 e main st; clarinda IA 51632
• Manufacturer (Section G): EZ WAY INC; 710 east main street; clarinda IA 51632
• Manufacturer Contact: amy scott ; 710 east main st; clarinda, IA 51632 ; 7125421814
• MDR Report Key: 19485139
• Report Number: 2183887-2024-00001
• Device Sequence Number: 8110279
• Product Code: FSA
• UDI-Device Identifier: 00848914000019
• UDI-Public: (01)00848914000019
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2024

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: 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: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2024
• Supplement Report FDA Received Date: 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/06/2021
• 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
• Patient Sex: Unknown