MAUDE Adverse Event Report: LIKO AB LIKORALL 242 S, WHITE; LIFT, PATIENT, NON-AC-POWERED

Model Number	3122010
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	09/02/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer alleged the lift¿s motor was nonfunctional after a battery change there was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).
Additional Manufacturer Narrative
Upon inspection, the technician found the emergency stop was disconnected.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 field service technician reconnected the connector to resolve the alleged issue.The technician performed functional and visual tests per the service manual to verify the lift functioned as designed.The instruction for use for likorall 242 s (7en120115 rev.14) describes in text and with pictorial illustrations how the mechanical emergency lowering shall be used.It additionally states that the product has an expected service life of 10 years when correctly handled, serviced and periodically inspected in accordance with liko instructions.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 have no damage.Activate the emergency stop button.Verify that t holds and locks in the activated position.Although there was no associated injury reported with this event, if the emergency stop button were to become detached and stop functioning during patient transfer it could lead to serious injury or death, therefore hillrom/baxter is conservatively reporting this event.

• Brand Name: LIKORALL 242 S, 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: 20350886
• Report Number: 8030916-2024-00067
• Device Sequence Number: 8053324
• Product Code: FSA
• UDI-Device Identifier: 00887761979819
• UDI-Public: 010088776197981911220804
• 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,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/02/2024

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: 3122010
• 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: 09/13/2024
• Initial Report FDA Received Date: 10/02/2024
• 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