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

Model Number	3121001
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report that likorall 200 had a ceiling strap detachment, it suddenly dropped.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The service technician inspected the lift and found that it was shaft breakage.A functional test of the single fault safety (sfs) safety drum was performed.The result from the test was that the sfs safety drum was functioning as designed.This motor shaft breakage is determined to be caused by a mechanical malfunction.The technician replaced the lift with a new one to resolve the reported event.Based on this information, no further action is required.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.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this device.It is unknown if the facility performs preventative maintenance on their device.

• 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, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24811018
• Report Number: 8030916-2026-00038
• Device Sequence Number: 10678527
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: (01)00887761981911
• 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,Followup
• Report Date (Section B): 06/10/2026

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: 3121001
• Device Catalogue Number: 3121001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/13/2026
• Supplement Date Received by Manufacturer: 05/18/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 06/10/2026
• 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