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

Model Number	2020003
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/11/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician replaced the power cable to resolve the issue.The sabina sit-to-stand lift is especially designed for people who have difficulty in standing up on their own from a seated position.Sabina sit-to-stand lift is intended for use with patients who are able to actively participate in the raising motion.When standing, they can be moved to a wheelchair or to a toilet, this gives them standing practice in connection with the transfer.Even as liko lifts comply to the above mentioned electrical standard, there is still a risk that abnormal wear and tear can damage the cables.Therefore, the periodic inspection manual for liko mobile lifts 3en371001 rev.5 states under section 8: check cables and connectors for damage or wear.Although the reported event did not result in a serious injury, a damaged power cable with exposed copper wires could contribute to a serious injury or death, if the malfunction were to recure.Therefore, baxter considers this complaint a reportable malfunction.
Event or Problem Description
The customer reported to baxter that the sabina ii had a broken power cord.Upon inspection, the baxter technician found the power cord was damaged with exposed copper wires.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.

• Brand Name: LIKO 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: 21641224
• Report Number: 8030916-2025-00053
• Device Sequence Number: 6668353
• Product Code: FSA
• UDI-Device Identifier: 00887761981782
• UDI-Public: (01)00887761981782
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Report Date (Section B): 03/19/2025

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: 2020003
• Device Catalogue Number: 2020003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2025
• Initial Report FDA Received Date: 03/19/2025
• 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