MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 242 S R2R, NATURAL; LIFT PATIENT NON AC POWERED

Model Number	3122011
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Fell (4014)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional contacted technical service to report that the patient dropped during lift from wheelchair,.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
Device inspection is sill pending at the facility.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
Likorall overhead lift is intended for use in, health care, intensive care and rehabilitation.Likorall overhead lift is designed for fixed installation and free-standing lift systems.All common lifts and transfers can be performed using likorall overhead lift, for instance between bed/wheelchair, to/from floor, toilet visits, gait training, and together with stretchers.Likorall r2r (room to room) overhead lift enables the patient to be moved between two rail systems in separate rooms.Likorall overhead lift with the es designation is prepared for operation with the wireless handcontrol remote (ir) and in addition, a transfer motor can be connected for motor driven movement along the rail.Likorall s, irc overhead lift is prepared for continuous charging through the railsystem.Upon inspection, baxter manufacturing site determined that the shaft had broken but the single fault safety drum functioned as designed.A replacement likorall 242 s quote was sent to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of patient fall were to recur, it could potentially cause serious injury or death.Therefore, baxter is reporting this event.

• Brand Name: LIKORALL 242 S R2R, NATURAL
• 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, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 23484268
• Report Number: 8030916-2025-00130
• Device Sequence Number: 21456065
• Product Code: FSA
• UDI-Device Identifier: 00887761979444
• UDI-Public: (01)00887761979444
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 03/04/2026

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: 3122011
• Device Catalogue Number: 3122011
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 02/05/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 03/04/2026
• 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