MAUDE Adverse Event Report: LIKO AB LIKORALL 243 ES, WHITE; LIFT, PATIENT, NON-AC-POWERED

Model Number	3123002
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field service technician replaced the gable assembly to resolve the alleged issue.The technician performed a functional test per the service manual to verify the lift functioned as designed.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.The periodic inspection manual for overhead lists 3en191001 rev 2, also states the following caution: 5 emergency stop: ¿ check that the emergency stop cord is secured properly and has no damage.¿ activate the emergency stop button.Verify that holds and locks in the activated position.Although there was no injury reported, if the emergency button were to fail during patient use, it could lead to a serious injury or death, therefore, baxter is reporting this malfunction.
Event or Problem Description
The service technician found that while performing annual pm technician functionally inspected that cpr feature would not engage.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: LIKORALL 243 ES, WHITE
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20062757
• Report Number: 8030916-2024-00053
• Device Sequence Number: 8496317
• Product Code: FSA
• UDI-Device Identifier: 00887761979543
• UDI-Public: 010088776197954311171120
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/26/2024

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
• Device Model Number: 3123002
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2024
• Initial Report FDA Received Date: 08/26/2024
• 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