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	Laceration(s) (1946)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On 13-feb-2025, a other health care professional contacted technical service to report that 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 caregiver.The incident related to the patient will be addressed separately.It was reported that the caregiver sustained a wound on the forehead.It was reported that the caregiver was transferred to the local emergency room for care, and it is noted the wound was closed with 2 stitches.
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.In this event, the customer reported that the caregiver required 2 stitches for the wound on the forehead.A laceration is a disruption of the skin, commonly called a cut, and can have clean straight edges or jagged edges.The caregiver required sutures to close the laceration to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes a serious injury occurred.
Additional Manufacturer Narrative
Correction to: b1, b2, b6, b7, d5, d9, d10, g4 (pma/510k # or bla #), g4: combination product, b5: it was reported the caregiver of a patient sustained a wound to the forehead while transferring a patient via a likorall overhead lift.During a patient transfer, ¿the engine detached from the it¿s axle¿ and fell making contact to the caregiver¿s forehead.The caregiver ¿was transferred to the local emergency services¿.The caregiver required two stitches to the forehead.Additional information received implies that the event was attributed to ¿human error¿ due to the caregiver¿s ¿mispositioning of the lift's engine¿.There was no malfunction of the device.Additional training for the use of the device was performed following the event, and additional training is ongoing.No further information was available at the time of this report.H11: should additional relevant information become available, a supplemental report will be submitted.

• 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: 21514869
• Report Number: 8030916-2025-00042
• Device Sequence Number: 15455325
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: (01)00887761981911
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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,Followup
• Report Date (Section B): 04/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3121001
• Device Catalogue Number: 3121001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2025
• Supplement Date Received by Manufacturer: 03/31/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/14/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female