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

Model Number 3122006

Device Problems Break (1069); Mechanical Problem (1384)

Patient Problems Bruise/Contusion (1754); Pain (1994); Concussion (2192)

Event Date 07/25/2023

Event Type  Injury  

Manufacturer Narrative

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.In this event, it is currently unknown if the reported injury sustained by the patient resulted in a permanent impairment of a body function or permanent damage to a body structure.It is unknown at this time whether medical and/or surgical intervention was required.However, it is reasonable to conclude due to the multiple traumatic injuries reported that medical intervention was required to preclude permanent impairment of body function or permanent damage to a body structure, concluding that a serious injury occurred.Additionally, device inspection is pending at this time.Investigation is on-going, and any additional and relevant information that is received in the course of the investigation will be documented in a final report.

Event Description

It was reported that the likorall 242 lift¿s motor had snapped causing the client to be dropped and injured.The patient suffered a concussion as a result of impact to the back of head followed by front of head impact with whiplash, strained muscles to the neck, both shoulders (especially right) and upper back, bruising under the buttock and thigh, small shards of toilet seat stuck in thigh, and a bruised and swollen foot.Specific details of the event including medical/surgical intervention provided, the patient¿s medical history, accessory devices utilized, and patient's outcome were not provided.This incident was captured under hillrom complaint ref # (b)(6).

Manufacturer Narrative

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 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.The device was returned for inspection, and it was confirmed that the lift's motor shaft had broken.Furthermore, it was observed that the secondary system's safety drum was also defective.It was concluded that the defect on the safety drum caused the patient drop to be longer before the lift's single fault system (sfs) was activated, resulting in a patient drop for a longer distance and with a higher velocity.No additional information regarding the patient¿s injury has been received.In this event, it is currently unknown if the reported injury sustained by the patient resulted in a permanent impairment of a body function or permanent damage to a body structure.Additional information were requested, however, it is unknown at this time whether medical and/or surgical intervention was required.Based on the information available, it is reasonable to conclude due to the multiple traumatic injuries reported, that medical intervention was required to preclude permanent impairment of body function or permanent damage to a body structure, concluding that a serious injury occurred.Additionally, the device inspection noted that the event was likely caused by the device's safety drum being defective, in addition to the motor shaft breakage occurred during the patient transfer.If any additional and relevant information is received, the case will be re-assessed accordingly.Hillrom is reporting this event.

Event Description

It was reported that the likorall 242 lift¿s motor had snapped causing the client to be dropped and injured.The patient suffered a concussion as a result of impact to the back of head followed by front of head impact with whiplash, strained muscles to the neck, both shoulders (especially right) and upper back, bruising under the buttock and thigh, small shards of toilet seat stuck in thigh, and a bruised and swollen foot.Specific details of the event including medical/surgical intervention provided, the patient¿s medical history, accessory devices utilized, and patient's outcome were not provided.This incident was captured under hillrom complaint ref # (b)(4).

• Brand Name: LIKORALL 242 ES, WHITE
• 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: 18410170
• MDR Text Key: 331513901
• Report Number: 8030916-2023-00088
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: NZ
• 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,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3122006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/10/2023
• 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
• Patient Weight: 110 KG