MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKO M220; LIFT PATIENT NON AC POWERED

Model Number	2050010
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information has been requested from the customer regarding the reported malfunction.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A other health care professional contacted technical service to report that liko m220 had an issue, alleged the item that connects the sling bar to the lift is broken.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 customer reported that the product is not available for service/inspection by baxter.
Additional Manufacturer Narrative
Universal slingbar can be used in combination with liko slings that attaches to the sling bar using sling loops.Liko´s universal sling bars are with two assembly options, fixed assembly or with quick-release hook.Item number 20590006 (slingbar liko 450) was identified as the item needing to be replaced.Multiple attempts were made to obtain additional information regarding the reported malfunction without response.A root cause of the reported incident can not be determined at this time.If any additional relevant information is received regarding this case , it will be submitted in a supplemental report.
Event or Problem Description
A other health care professional contacted technical service to report that liko m220 had an issue, alleged the item that connects the sling bar to the lift is broken.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 customer reported that the product is not available for service/inspection by baxter.

• Brand Name: LIKO M220
• 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: 23109327
• Report Number: 8030916-2025-00111
• Device Sequence Number: 9871082
• Product Code: FSA
• UDI-Device Identifier: 00887761981898
• UDI-Public: (01)00887761981898(11)190717
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/20/2025

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: 2050010
• Device Catalogue Number: 2050010
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/25/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/22/2025
• Supplement Report FDA Received Date: 11/20/2025
• 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
• Patient Sex: Unknown