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

Model Number	3121001
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Fell (4014)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 15-jan-2026, a distributor contacted technical service to report that likorall 200 (product code 3121001, serial number (b)(6)), the axle between the motor and safety drum broke and for that reason patient dropped approx 25-30cm.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
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 completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
The baxter technician found the motor shaft broken.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.The issue was resolved by providing the customer with a new lift.

• 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: 24307678
• Report Number: 8030916-2026-00012
• Device Sequence Number: 13181439
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: (01)00887761981911
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown