MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL OVERHEAD LIFT; LIFT PATIENT NON AC POWERED

Model Number	U3122009
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Erythema (1840)
Date of Event	02/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A customer reported the likorall 242 overhead lift motor fell on the female caregiver causing redness to her right wrist.Treatment was reported as application of hemoclar cream.There was no patient in the lift at the time of the reported event.
Additional Manufacturer Narrative
Likorall overhead lift is intended for use in, health care, intensive care and rehabilitation.Likorall overhead lift is designed for fixed installation and free-standing lift systems.All common lifts and transfers can be performed using likorall overhead lift, for instance between bed/wheelchair, to/from floor, toilet visits, gait training, and together with stretchers.Likorall r2r (room to room) overhead lift enables the patient to be moved between two rail systems in separate rooms.Likorall overhead lift with the es designation is prepared for operation with the wireless handcontrol remote (ir) and in addition, a transfer motor can be connected for motor driven movement along the rail.Likorall s, irc overhead lift is prepared for continuous charging through the railsystem.Baxter inspected the likorall 242 s overhead lift.The lift motor fell to the floor after passing the switch from the bathroom (straight rail) to the bedroom h rail).No electrical or mechanical anomalies were noted.The motor fell at the level of the likrorall switch caused by a handling error, further described as unlocking the switch in the wrong location on the rail system.Per the technician, a sticker is present on the device to warn the user of this.The institution¿s occupational therapist plans to raise staff awareness regarding proper use of the rails.The likorall 242 s motor was replaced.In this event, the caregiver sustained skin redness and was treated with a topical dermal cream.The reported event was not life threatening, and topical dermal cream is not considered medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, concluding no serious injury occurred.The cause of the event was attributed to use error, which would be likely to cause or contribute to a death or serious injury if the use error were to recur.

• Brand Name: LIKORALL OVERHEAD LIFT
• Common Device Name: LIFT PATIENT NON AC POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): LIKO AB; nedre vagen 100; lulea 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21631417
• Report Number: 8030916-2025-00051
• Device Sequence Number: 7536673
• Product Code: FSA
• UDI-Device Identifier: 00887761979796
• UDI-Public: (01)00887761979796
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: U3122009
• Device Catalogue Number: U3122009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/28/2025
• Initial Report FDA Received Date: 03/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Female