MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 243; LIFT PATIENT NON AC POWERED

Model Number	3123001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sling bar of the likorall 243 lift dropped during a transfer and made contact with the patient causing an injury.It was noted that the reporter was not at liberty to discuss the specific injury that resulted to the patient.Multiple attempts were made to obtain specific details about the reported injury and eventual medical/surgical intervention required; however, no additional information could be obtained from the customer.
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.The device ifu states: ¿before lifting, check that the quick-release hook is correctly attached to the q-link ii or q-link¿.An inspection performed by a baxter technician noted that the device was functioning as designed and is back in service.No malfunction was identified.In this event, the customer did not provide the necessary information to determine the severity of the reported injury.There was no indication that the reported injury was serious in nature, and there was no report of required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Therefore, this event will be assessed as non-serious injury.Additionally, there was no malfunction identified with the device, however, a use error in the attachment of the sling bar to the lift cannot be ruled out.If a similar event were to recur, and the lift¿s sling bar were to detach during transfer and make contact with the patient, it would be likely to cause or contribute to a serious injury or death.

• Brand Name: LIKORALL 243
• 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: 21195616
• Report Number: 8030916-2024-00138
• Device Sequence Number: 20722691
• Product Code: FSA
• UDI-Device Identifier: 00887761979529
• UDI-Public: (01)00887761979529(11)240820
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2025

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
• Operator of Device: Other
• Device Model Number: 3123001
• Device Catalogue Number: 3123001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2024
• Initial Report FDA Received Date: 01/21/2025
• 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: Unknown