MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKO M230; LIFT PATIENT NON AC POWERED

Model Number	2050015
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/10/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon visual inspection, the emergency button was found to be inoperative due to the internal part not being screwed in.Liko m220 and m230 mobile lifts are easy-to-use mobile lifts primarily intended for use in nursing homes.Both models are excellent aids for daily transfers of adults and children; for instance, for transfers to and from a wheelchair, toilet and floor.The models differ in the way the base width is adjusted while both lifts feature an electric lift mechanism.Liko m230 mobile lift has an electric base and liko m220 mobile lift a manual base for opening and closing the legs.The baxter technician repaired the emergency stop button to resolve and the device was working as intended.Although there was no adverse event reported if the emergency stop button was not functional during a patient transfer it could lead to serious injury or death therefore baxter is reporting this malfunction.
Event or Problem Description
A distributor contacted technical service to report that liko m230 emergency stop button was faulty and needed to be replaced.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: LIKO M230
• 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: 21078428
• Report Number: 8030916-2024-00132
• Device Sequence Number: 15178048
• Product Code: FSA
• UDI-Device Identifier: 00887761981904
• UDI-Public: (01)00887761981904
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/06/2025

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
• Operator of Device: Other
• Device Model Number: 2050015
• Device Catalogue Number: 2050015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2024
• Initial Report FDA Received Date: 01/06/2025
• 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