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

Model Number	U3122009
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
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
The customer reported that "the strap was damaged as a result of a fall" 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 found that the strap was damaged as a result of a fall.The technician was contacted for additional information about the event.It was confirmed that the lift did not fall during patient handling, it was dropped from a trolley by someone, which caused the mechanical emergency lowering to brake.The lift strap had signs of wear so it was replaced at the same time by the technician.Based on this information, the issue is determined to be caused by abuse.Reports of physical damage by the end user would be evident.The end user should return the device for service and replace the device.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.
Event or Problem Description
The customer reported that "the strap was damaged as a result of a fall" 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 242 S, NATURAL
• 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: 23152966
• Report Number: 8030916-2025-00113
• Device Sequence Number: 18678338
• Product Code: FSA
• UDI-Device Identifier: 00887761979796
• UDI-Public: (01)00887761979796
• 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): 11/28/2025

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: U3122009
• Device Catalogue Number: U3122009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 11/26/2025
• Initial Report FDA Received Date: 09/26/2025
• Supplement Report FDA Received Date: 11/28/2025
• 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