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

Model Number	3122007
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation determined that the incident had occurred approximately 2 years prior during installation, the ceiling track holes had been drilled insufficiently by a third party provider causing the safety bar on the switch system to catch allowing the motor to fall from the rail.The third party installer modified the track gate to ensure that the holes in the rails were properly aligned.The electronic card and cover was replaced to resolve the damage on the lift motor.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 hand control 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 rail system.The installation handbook for liko overhead rail systems (3en680001 rev.19) outlines the proper instructions for installation guidelines for the overhead system.Although there was no patient injury associated with the reported event, if this type of malfunction were to recur, it could contribute to a serious injury or death.Therefore, baxter considers this complaint a reportable malfunction.
Event or Problem Description
The distributor contacted technical service to report that the likorall 242 es r2r motor fell from rail.When the staff were moving the hoist between tracks via the track gate, the hoist moved off the end of the track and fell on to the floor damaging the end cover.The device was not being used by a patient at the time.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: LIKORALL 242 ES 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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20621056
• Report Number: 8030916-2024-00095
• Device Sequence Number: 21051296
• Product Code: FSA
• UDI-Device Identifier: 00887761979758
• UDI-Public: (01)00887761979758(11)220117
• 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): Y
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Repair
• Type of Report: Initial
• Report Date (Section B): 11/06/2024

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
• Operator of Device: Other
• Device Model Number: 3122007
• Device Catalogue Number: 3122007
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown