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

Model Number	3122010
Medical Device Problem Codes	Mechanical Problem (1384); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Fall (1848); Hematoma (1884)
Date of Event	08/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a likorall 242 lift was involved in a patient fall.The sequence of events surrounding the fall was not provided.However, the customer reported that the patient sustained a ¿bump on the head¿ and ¿fell on his buttocks.¿ medical intervention was not reported.
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.An inspection of the device performed by a baxter technician noted that the lift¿s hydraulic block axle was broken.The customer was provided an estimate for repair.Based on the details provided by the customer, the patient sustained a bump on the head, with no noted injury as a result of falling on the buttocks.A bump or hematoma is an injury to tissues with skin discoloration and without breakage of skin.Blood from the broken vessels accumulates in surrounding tissues, which may produce pain, swelling, tenderness, and discoloration of the skin.Non-severe hematomas heal without treatment, cold compresses may reduce bleeding if applied immediately after the injury, and may reduce swelling, discoloration, and pain.In this event, a serious injury did not occur, the patient did not sustain permanent impairment of a body function or permanent damage to a body structure, and there was no report of required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes that no serious injury occurred.The device has been requested to be returned to the manufacturer for further inspection.A final report will be submitted upon completion of the investigation.
Additional Manufacturer Narrative
The service technician inspected the lift and found that the hydraulic bloc axle (motor shaft) was broken.The unit was returned to lulea site for investigation.The unit was disassembled and the motor shaft breakage was confirmed.A functional test of the single fault safety (sfs) safety drum was performed.The result from the test was that the sfs safety drum was functioning as designed.This issue is determined to be caused by a mechanical malfunction (motor shaft breakage).Based on the details provided by the customer, the patient sustained a bump on the head, with no noted injury as a result of falling on the buttocks.A bump or hematoma is an injury to tissues with skin discoloration and without breakage of skin.Blood from the broken vessels accumulates in surrounding tissues, which may produce pain, swelling, tenderness, and discoloration of the skin.Non-severe hematomas heal without treatment, cold compresses may reduce bleeding if applied immediately after the injury, and may reduce swelling, discoloration, and pain.In this event, a serious injury did not occur, the patient did not sustain permanent impairment of a body function or permanent damage to a body structure, and there was no report of required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes that no serious injury occurred.A report of motor shaft breakage would be unlikely to cause or contribute to a death or serious injury, if the malfunction were to recur as the device has a secondary system with a safety drum that lowers the patient to the surface in a controlled and safe manner, in the event of a motor or transmission failure.This patented safety design provides protection against uncontrolled lowering.There are no risks identified for this failure due to the single fault system (sfs).After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.
Event or Problem Description
The customer reported that a likorall 242 lift was involved in a patient fall.The sequence of events surrounding the fall was not provided.However, the customer reported that the patient sustained a ¿bump on the head¿ and ¿fell on his buttocks.¿ medical intervention was not reported.

• Brand Name: LIKORALL 242
• 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: 23051156
• Report Number: 8030916-2025-00108
• Device Sequence Number: 9769717
• Product Code: FSA
• UDI-Device Identifier: 00887761979819
• UDI-Public: (01)00887761979819
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/22/2025

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: 08/18/2025
• Supplement Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/22/2025
• 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