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

Model Number	3122008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The unit was returned to the manufacturer for investigation where the unit was disassembled and the motor shaft breakage was confirmed.A functional test of the single fault safety (sfs) safety drum was performed by manually pulling the lift strap and check for the sfs to start adding resistance to the lift strap.The result from the test was that the sfs safety drum was not responding as rapidly as expected.After the functional test was performed, the sfs safety drum was opened to examine the oil level.The oil level was found to be below the specifications, which explains why the sfs safety drum was not responding as rapidly as expected during the functional test.The returned unit showed no signs of leakage when it arrived at the site.No visible stains that could indicate earlier leakages.The unit was replaced for the customer.The 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.Although there was no reported injury associated with this incident, reports of a motor shaft breakage where the sfs did not function as intended could lead to serious injury or death.Baxter is reporting this malfunction.
Event or Problem Description
Baxter received a customer complaint reporting the likorall 242 es r2r, had a shaft breakage where the user has fallen back down into their standing support.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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: 21503018
• Report Number: 8030916-2025-00040
• Device Sequence Number: 8020482
• Product Code: FSA
• UDI-Device Identifier: 00887761979772
• UDI-Public: (01)00887761979772
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 03/03/2025

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: 3122008
• Device Catalogue Number: 3122008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/06/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 03/03/2025
• 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