MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL OVERHEAD LIFT; LIFT PATIENT NON AC POWERED

Model Number	3122010
Medical Device Problem Codes	Use of Device Problem (1670); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional contacted technical service to report that the likorall 242 s, white had an issue, when inspecting a likoral 242's lift, the liftstrap was changed and when testing the manual emergency lowering, the lift strap slid uncontrollably straight through at first ¿hand pumping¿.Usually you get to ¿pump¿ down type 6-7 cm at a time at 60 kg sample weight.This occurred during biomed testing.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.
Additional Manufacturer Narrative
The device has been requested to be returned for inspection into the reported malfunction.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Three lift straps were returned to lulea for investigation.A sample analysis was performed.A visual inspection showed no deviations.Functional test of the lift straps were performed and the mechanical emergency lowering functioned as intended.If the emergency lowering handle is held down, the strap slides through the strap joint.When the handle is released, the lowering stops.The correct way to use the mechanical lowering function (moving the handle up and down / pumping) is described in the user manual 7en120115.This issue is unlikely to cause or contribute to serious injury or death if to recur.If this were to occur during patient use, the lift would be considered non-functional and the end user would find another mean to lower the patient while he/she is still secured in the sling.
Event or Problem Description
A other health care professional contacted technical service to report that the likorall 242 s, white had an issue, when inspecting a likoral 242's lift, the liftstrap was changed and when testing the manual emergency lowering, the lift strap slid uncontrollably straight through at first ¿hand pumping¿.Usually you get to ¿pump¿ down type 6-7 cm at a time at 60 kg sample weight.This occurred during biomed testing.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: LIKORALL OVERHEAD 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 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22016856
• Report Number: 8030916-2025-00074
• Device Sequence Number: 18494658
• Product Code: FSA
• UDI-Device Identifier: 00887761979819
• UDI-Public: (01)00887761979819
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 07/04/2025

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: 3122010
• Device Catalogue Number: 3122010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2025
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 05/14/2025
• Supplement Report FDA Received Date: 07/04/2025
• 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