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

Model Number	2010004
Medical Device Problem Code	Device Tipped Over (2589)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the third party technician, it was confirmed when standing on the lift legs facing the lift arm and deflecting the lift arm to the right, the rear left caster lifted off the floor by about 3 inches.This confirmed there was unacceptable movement in the base assembly.Uno 102 mobile lift has electric raising and lowering of the lift arm.Uno mobile lift is intended mainly for use in post acute care facilities like nursing homes and other care homes in the most common lifting situations, for instance, transfers between bed and wheelchair, to and from toilet and for lifting to and from the floor.Uno mobile lift has three alternative height settings, in order always to provide the optimum lifting height.The third party technician concluded that the legs and the crossmember mast weldment would need replacing to resolve the issue.Although there was no injury reported, if the lift were to tilt/ tip over during patient use, it could cause or contribute to a death or serious injury if this were to recur.
Event or Problem Description
A customer contacted technical service to report that the uno 102 ee lift had an issue, customer alleges that the lift is tipping to the right.The process step during which this occurred was unknown.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.

• Brand Name: LIKORALL MOBILE 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: 21761069
• Report Number: 8030916-2025-00060
• Device Sequence Number: 12964663
• Product Code: FSA
• UDI-Device Identifier: 00887761981775
• UDI-Public: (01)00887761981775
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/03/2025

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: 2010004
• Device Catalogue Number: 2010004
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Initial Report FDA Received Date: 04/03/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown