MAUDE Adverse Event Report: LIKO AB LIKO M220; LIFT, PATIENT, NON-AC-POWERED

Model Number 2050010

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

Hillrom is in the process of contacting the customer to obtain additional information on the reported event, including chain of events, injury details and patient outcome, at this time no further information was provided.Therefore, it is currently unknown if the reported injury resulted in a permanent impairment of a body function or permanent damage to a body structure, and if any medical and/or surgical intervention was required to preclude permanent impairment of body function or permanent damage to a body structure.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

On the 16th of november 2023, hillrom received a user report for m bfarm with the following description of the event: "according to the staff, the lift simply sank at high speed while the patient was in the lift sling.There was personal injury." this report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

Liko m220 and m230 mobile lifts are easy-to-use mobile lifts primarily intended for use in nursing homes.Both models are excellent aids for daily transfers of adults and children; for instance, for transfers to and from a wheelchair, toilet and floor.The models differ in the way the base width is adjusted while both lifts feature an electric lift mechanism.Liko m230 mobile lift has an electric base and liko m220 mobile lift a manual base for opening and closing the legs.Multiple attempts were performed to obtain additional information on the reported event, including chain of events, injury details and patient outcome, however, the customer did not provide any further detail.The lift was returned partially disassembled and in poor hygienic condition.An inspection performed by a baxter technician noted that the two rear brake wheels were loose and not screwed down correctly.The cover caps of the wheels and the lift's power cord were also missing.All other components of the lift were functioning as designed.Weight test at maximum load was performed and no issues were noted.The periodic maintenance sticker was not found, therefore, the date of the latest periodic inspection is unknown.In this event, the customer noted that there was "personal injury", however, despite multiple follow-up attempts, it is unknown if the reported injury resulted in a permanent impairment of a body function and/or if the patient required a medical intervention to preclude permanent damage to a body structure, concluding that the severity of the injury is undetermined at this time.Additionally, based on the limited information provided, it is reasonable to conclude that it is unlikely that the secondary findings identified during device inspection caused or contributed to the reported incident.Therefore, the exact cause of the reported event is currently undetermined.If any additional and relevant information is received it will be submitted in a supplemental report.

Event Description

On the 16th of november 2023, hillrom received a user report for m bfarm with the following description of the event: "according to the staff, the lift simply sank at high speed while the patient was in the lift sling.There was personal injury.".This report was filed in our complaint handling system as (b)(4).

• Brand Name: LIKO M220
• 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: 18324109
• MDR Text Key: 330478784
• Report Number: 8030916-2023-00084
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 2050010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/16/2023
• 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 Age: 55 YR
• Patient Sex: Male