MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 250 ES, WHITE; LIFT PATIENT NON AC POWERED

Model Number	3122502
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	06/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During follow up with the technician, it was clarified that there was no patient fall, no defects were found on the lift strap and it was intact.The service technician could not perform a load test since the lift's batteries were uncharged at the customer facility.The likorall ifu states the following: before lifting, always make sure that: ¿ the lifting accessory is selected appropriately, in terms of type, size, material and design with regard to the patient¿s needs.¿ the lift strap is not twisted or worn and can move in and out of the lift freely.¿ the lifting accessories are not damaged.¿ the lifting accessory is correctly and safely applied to the patient in order to prevent injuries.¿ the lifting accessory is properly attached to the lift.¿ the lifting accessory hang vertically and can move freely.¿ the latches are intact; missing or damaged latches must always be replaced.¿ the sling¿s strap loops are correctly connected to the sling bar hooks when the sling straps are extended upwards, but before the patient is lifted from the underlying surface.Based on the provided information, the likely cause is that the lift strap had been incorrectly folded, and when the patient was lifted the folded part of the lift strap released causing the liftstrap to drop.
Event or Problem Description
A other health care professional contacted technical service to report that the likorall 250 es, white had an issue, the safety cable did not get stuck when a patient fell.This occurred during patient use.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
An inspection of the device showed no defects found on the strap but the battery was dead and was replaced to resolve.Additional information has been requested regarding the device inspection and determined root cause of the reported event.A final report will be submitted upon completion of the investigation.
Event or Problem Description
A other health care professional contacted technical service to report that the likorall 250 es, white had an issue, the safety cable did not get stuck when a patient fell.This occurred during patient use.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 250 ES, WHITE
• 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: 22437687
• Report Number: 8030916-2025-00086
• Device Sequence Number: 20010785
• Product Code: FSA
• UDI-Device Identifier: 00887761979505
• UDI-Public: (01)00887761979505
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2025

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: 3122502
• Device Catalogue Number: 3122502
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 08/14/2025
• 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