MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 242 S, WHITE; LIFT PATIENT NON AC POWERED

Model Number	3122010
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested regarding the reported incident.A final report will be submitted upon completion of the investigation.
Event or Problem Description
A other health care professional contacted technical service to report that during the transfer of a resident, the load-bearing strap failed.Luckily, they were above the bed at the time of the incident, which prevented any injuries.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.The device was requested for service/inspection by baxter.
Event or Problem Description
A other health care professional contacted technical service to report that during the transfer of a resident, the load-bearing strap failed.Luckily, they were above the bed at the time of the incident, which prevented any injuries.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.The device was requested for service/inspection by baxter.
Additional Manufacturer Narrative
The service technician inspected the lift and found the motor axle (shaft) was broken.The technician was contacted for additional information about the event and the technician confirmed that the electrical motor was replaced to resolve the alleged issue.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.A report of motor shaft breakage would be unlikely to cause or contribute to a death or serious injury, if the malfunction were to recur as the device has a secondary system with a safety drum that lowers the patient to the surface in a controlled and safe manner, in the event of a motor or transmission failure.This patented safety design provides protection against uncontrolled lowering.There are no risks identified for this failure due to the single fault system (sfs).After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.

• Brand Name: LIKORALL 242 S, WHITE
• 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 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23165962
• Report Number: 8030916-2025-00115
• Device Sequence Number: 12982208
• Product Code: FSA
• UDI-Device Identifier: 00887761979819
• UDI-Public: (01)00887761979819
• 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,Followup
• Report Date (Section B): 11/13/2025

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: 3122010
• Device Catalogue Number: 3122010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/04/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 09/29/2025
• Supplement Report FDA Received Date: 11/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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