MAUDE Adverse Event Report: HILL-ROM/LIKO AB LIKO LIKORALL 243 ES; LIFT, PATIENT, NON-AC-POWERED

Model Number 3123001NA

Device Problems Fail-Safe Problem (2936); Mechanics Altered (2984)

Patient Problem Fall (1848)

Event Date 05/25/2023

Event Type  Injury  

Event Description

On (b)(6) 2023.The ceiling lift failed during a transfer of the patient from wheelchair into bed.Safe patient handling coordinators went over to inspect the lift.Noted the lift would not go up, only down when the "up" button was pressed.Unit entered work order.On 5/26/23.(b)(6) spoke with the visn contract repair technician who reported the gear that bears weight is not working.If patient was lifted when the gear gave out, the patient would have dropped, like a previous incident.Tech removed lift from the room and staff advised to use portable patient lift.On 5/30/23.Liko rep notified and spoke on the phone.He agreed to do a complete sweep/inspection of the rest of the ceiling lifts (model 243, 507 bs.) to determine what the problem is.On 5/31/23.Liko rep came out to see the lift.He took a photo of the manufacturer sticker.We discussed a liko tech will be out to open up the lift for information.Awaiting date that tech will do the complete sweep/inspection of the rest of the ceiling lifts.Similarly, on (b)(6) 2021, with the same model of lift, nursing staff on the same spinal cord injury unit, applied sling to patient in a different room.The lift had worked just a few minutes before and they lowered it to attach the sling.With the patient all hooked up to the lift, they began to raise the lift and the lifting strap just gave way and dropped the patient on the bed.No time to reach for emergency cord.Patient was assessed for injury.No injury found.Safe patient handling coordinator spoke with staff, contract repair team, engineering, and liko vendor rep.No user error identified.Repair team identified the same issue with malfunctioning gear where the gears were just spinning instead of catching to stop the lift appropriately.These likorall 243 ceiling lifts were manufactured 2017 and installed february 2018.Reference report: mw5118159.

• Brand Name: LIKO LIKORALL 243 ES
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): HILL-ROM/LIKO AB
• MDR Report Key: 17070481
• MDR Text Key: 316698856
• Report Number: MW5118158
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3123001NA
• 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