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

Model Number P3122009

Device Problem Insufficient Information (3190)

Patient Problem Abrasion (1689)

Event Date 12/12/2023

Event Type  malfunction  

Manufacturer Narrative

During follow-up, the customer confirmed the patient was a 80-year-old-male (63 kg, 1.71m) and did not require any medical intervention, the reported injury was defined as a ¿carpet burn¿, which came from rubbing the wheelchair".The lift involved in this event was removed from service and will be inspected.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 rail system.A ¿carpet burn , known more precisely as a friction burn, is caused when a section of skin comes in contact with an abrasive surface at such a high speed that it scrapes off one or more layers of skin.A friction burn can happen when the skin scrapes across an abrasive surface or an abrasive surface is scraped across the skin.The treatment of a friction burn varies by how many layers of skin have been removed and how large the wound is.Some cases can be treated at home, while others require medical treatment and hospitalization.In this event, the injury sustained by the patient ("carpet burn") did not require medical intervention to preclude permanent impairment of body function or permanent damage to a body structure, which concludes that a serious injury did not occur in this case.If this event were to recur (the lift strap dropping out of the lift at a length resulting in a patient fall) it is likely to result in serious injury.The exact cause of the reported event is undetermined at this time.The lift has been requested to be returned for inspection.Investigation is on-going, any additional and relevant information that is received in the course of the investigation will be documented in a final report.

Event Description

The customer initially reported that during the transfer of a patient with a likorall 242 lift, the lift strap dropped out of the lift, the patient fell and sustained injury/scratches.This incident was captured under hillrom complaint ref (b)(4).

Event Description

The customer initially reported that during the transfer of a patient with a likorall 242 lift, the lift strap dropped out of the lift, the patient fell and sustained injury/scratches.This incident was captured under hillrom complaint ref (b)(4).

Manufacturer Narrative

The unit was returned to the manufacturer for inspection where it was determined that the motor shaft had broken.The field service technician replaced the motor to resolve the alleged issue.The technician performed functional and visual tests per the service manual to verify the lift functioned as designed.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.The technical requirements of patient lifts are regulated worldwide by the standard hoists for the transfer of disabled persons - requirements and test methods (iso 10535).As per iso 10535 it is acceptable to have a secondary system that becomes activated and prevents the patient from falling in case the primary system fails.Hillrom has met the requirement for a secondary system with a safety drum that lowers the patient to the surface in a controlled and safe manner, in the event of a motor or transmission failure.This patented safety design provides protection against uncontrolled lowering.There are no risks identified for this failure due to the single fault system (sfs).If the malfunction were to occur during use, the single fault safety system would activate to prevent the patient from falling too far at a high speed.There is no indication at this time that the secondary system failed.If additional information is obtained, the case will be re-assessed accordingly.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.Hillrom does not consider this to be a reportable malfunction.

• Brand Name: LIKORALL 242 S, NATURAL
• Type of Device: 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: 18482458
• MDR Text Key: 332498451
• Report Number: 8030916-2024-00001
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 01/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3122009
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 171 KG