MAUDE Adverse Event Report: ETAC MOLIFT SMARTLIFT 150; LIFT, PATIENT, NON-AC-POWERED

Model Number N10200

Device Problems Nonstandard Device (1420); Device Slipped (1584)

Patient Problems Bruise/Contusion (1754); Fall (1848); Headache (1880); Inflammation (1932); Pain (1994); Unspecified Tissue Injury (4559)

Event Date 09/16/2021

Event Type  Injury  

Event Description

I have als and am nearly 100% paralyzed.I had my two caretakers, one being a nurse transferring me from bed to wheelchair.The right rear strap of the sling slipped out of the round hook during the transfer causing a fall from maximum elevated height the lift has.It caused me to fall backwards landing on my head and right side.My head hit the floor and my body landed across the hoyer legs.It was miraculous that my neck did not break based on how i landed.I wear non invasive ventilation (bipap) which luckily remained in tact and on my face.My two caregivers were able to prop me up to assist my breathing until 9 emt's arrived to help.My head, my artificial hip, my ribcage and left hand were all injured in the fall.Luckily nothing is broken, but it will be a very long road for recovery.Typically if an als patient has a fall they can have a decline after it, i am hoping this will not be the case as i don't have a lot to give.I did call the company etac which makes the lift.The gentleman told me that there was a recall years ago on the clip that used to be on the hook, but they "kept breaking" so they stopped using them.No part ever replaced it.This is a problem that should be addressed as i know this lift is used for the elderly and disabled.This accident has changed my life and the little mobility i had left and for the cost of a few dollar for a latch or hook it could have been avoided.A long road with inflammation.I could not have an mri or cat scan because i can not lay down.Hopefully the head is not injured or bleeding.It is now over three weeks, and i still am in a lot of pain with my hip, a dull headache, and my hand is still not able to have the little bit of mobility it had.It is still black and blue as well.Fda safety report id# (b)(4).

• Brand Name: MOLIFT SMARTLIFT 150
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): ETAC
• MDR Report Key: 12583411
• MDR Text Key: 275515242
• Report Number: MW5104418
• Device Sequence Number: 1
• Product Code: FSA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N10200
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Disability
• Patient Age: 56 YR
• Patient Weight: 82