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

Model Number	3121001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	02/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that while transferring a patient using the likorall 200 overhead lift, the lift¿s motor detached from its axle and fell, hitting a caregiver¿s forehead and a patient¿s legs.The caregiver sustained a wound on the forehead and the patient sustained hematoma on the legs.This medical safety review will address the incident associated with the patient.The incident associated with the caregiver will be addressed separately.It was reported that the patient sustained a hematoma on the legs.The patient was evaluated by a doctor, and it was determined that no medical treatment was needed.
Additional Manufacturer Narrative
Likorall overhead lift is a stationary lift mounted in a rail system.The rail system can be built straight, with or without curves, as a traverse system, and also as a room-to-room system.Likorall overhead lift is intended for use in lifting and transferring patients, for example, from bed to a wheelchair, to or from the floor, for visits to the toilet, for gait, standing and balance training, when weighing the patient, and when lifting the patient with a stretcher.The baxter technician found no problems with the device during inspection, and after a discussion with the executive director at the facility, they agreed that the incident was caused by human error, and that the engine was mispositioned and that the device was not at fault.The likorall 200 instructions for use states the following: if the likorall is installed in the s65 carriage with single hook, make sure it is resting securely at the bottom of the hook and is not tilted.A hematoma or bruise is an injury to tissues with skin discoloration and without breakage of skin.Blood from the broken vessels accumulates in surrounding tissues, which may produce pain, swelling, tenderness, and discoloration of the skin.Most bruises/hematomas heal without treatment, cold compresses may reduce bleeding if applied immediately after the injury and may reduce swelling, discoloration, and pain.In this event, the patient reportedly sustained a hematoma on the legs, and no medical intervention was required.The patient did not sustain permanent impairment of a body function or permanent damage to a body structure, which concludes no serious injury occurred.However, if the reported incident were to recur (motor detaches from the rail) it is likely to cause or contribute to a death or serious injury.

• 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: 21515379
• Report Number: 8030916-2025-00043
• Device Sequence Number: 15458988
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: (01)00887761981911
• 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): 03/04/2025

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: 3121001
• Device Catalogue Number: 3121001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 03/04/2025
• 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