MAUDE Adverse Event Report: LIKO AB LIKORALL 250 ES, WHITE; LIFT, PATIENT, NON-AC-POWERED

Model Number	3122502
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged the patient was on a lift and the lift rail pulled out from the ceiling causing the patient to be dropped back into the chair.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This incident was captured under complaint ref#: (b)(4).
Additional Manufacturer Narrative
An inspection was performed at the facility by a third party company.The third party technician determined the issue was due to corrosion and repaired the lift support, ceiling and re-certified all the customer¿s patient lifts per the customer¿s request.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 liko overhead lifts 3en191001 states the following warnings: due to the environment an overhead system is installed in, components may be subject to corrosion.Check for visible severe corrosion and material loss and identify if components need to be replaced.The manual also states that liko overhead lifts must be thoroughly inspected at least once per year.It was reported that the lift had not been inspected within the last 12 months for this issue.Although there was no patient injury reported, if the liko lift support rail were to pull away from the ceiling during use it could lead to a serious injury or death.Baxter is reporting this malfunction.

• Brand Name: LIKORALL 250 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: 20370069
• Report Number: 8030916-2024-00068
• Device Sequence Number: 3745775
• Product Code: FSA
• UDI-Device Identifier: 00887761979505
• UDI-Public: 010088776197950511230603
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/04/2024

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: 3122502
• 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: 09/09/2024
• Initial Report FDA Received Date: 10/04/2024
• 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
• Patient Sex: Unknown