MAUDE Adverse Event Report: LIKO AB LIKORALL 200; OVERHEAD TRACK PATIENT LIFTING/TRANSFER SYSTEM

Model Number 3121001

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/20/2023

Event Type  malfunction  

Manufacturer Narrative

Upon inspection, the hrc technician determined that the emergency function was inoperative.The electric card and cover were replaced to resolve the reported issue.Likorall overhead lift is a stationary lift mounted in a rail system.The rail system can be built straight, with or without curves, as a traverse system and also as a room-to-room system.Likorall overhead lift is intended for use in lifting and transferring patients, for example, from bed to a wheelchair, to or from the floor, for visits to the toilet, for gait, standing and balance training, when weighing the patient and when lifting the patient with a stretcher.According to hillrom¿s periodic inspection for liko mobile lifts (3en371001 rev.4), the emergency stop function must be checked at least once every year.In the document it is stated under section 10: press the emergency stop button.With the emergency stop pressed in, verify the lift does not operate with the hand control buttons.Turn the red emergency button in the direction of the arrows.Verify the button releases from the locked position into the raised, open position.Although there was no reported injury as a result of the reported event, the report of an emergency button not functioning during patient transfer could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.

Event Description

The customer alleged the unit¿s cover was damaged.Details of the circumstances that lead to the malfunction were not provided.There was no patient or user injury reported.This report was filed in our complaint handling system as (b)(4).

• Brand Name: LIKORALL 200
• Type of Device: OVERHEAD TRACK PATIENT LIFTING/TRANSFER SYSTEM
• 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: 17542130
• MDR Text Key: 321106077
• Report Number: 8030916-2023-00057
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3121001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1