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

Model Number	3122012
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Pain (1994)
Date of Event	05/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that a likorall 242 lift was involved in a patient fall.The pictures provided by the customer showed that the lift strap broke.During follow-up the customer confirmed that ¿the patient had simple back, sacrum and rib pain, but after x-ray and scan nothing abnormal was found¿.
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.An inspection of the device performed by a baxter technician noted that the lift strap was in an advanced state of wear and it had not been replaced since 2014.The lift strap will be replaced to resolve the issue.Pain is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.It is not life-threatening and does not require treatment to prevent permanent impairment of a body function or structure.In this event, the patient did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, therefore, this event will be assessed as non-serious.The use of the device has probably contributed to the reported non-serious event.If a similar event were to recur, and the lift strap were to break during a patient transfer, it would be likely to cause or contribute to a serious injury or death.

• Brand Name: LIKORALL 242 S R2R, 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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22211953
• Report Number: 8030916-2025-00080
• Device Sequence Number: 8158731
• Product Code: FSA
• UDI-Device Identifier: 00887761979468
• UDI-Public: (01)00887761979468
• 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
• Report Date (Section B): 06/16/2025

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: 3122012
• Device Catalogue Number: 3122012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/16/2025
• 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 Age: 66 YR
• Patient Sex: Male