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

Model Number 2040045

Device Problem Naturally Worn (2988)

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

Event Date 09/13/2022

Event Type  malfunction  

Event Description

The customer reported the viking m lift was being used to transfer a patient weighing 258 lb from the bed to a shower chair when the sling bar broke and the patient fell on the shower chair.At the time of the initial report, the customer did not know if the patient suffered any injury.No medical intervention was reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

During a follow up call with the customer, the customer confirmed there was no patient injury from the fall.The patient subsequently died three days later.The customer declined to provide further details including the patient's determined cause of death or if the death was expected but again confirmed that no injury occurred from the fall.Viking m mobile lift is a general-purpose lift with the intended use in; health care, intensive care and rehabilitation.Viking m mobile lift is an excellent aid in daily transfers of both adults and children.With 3 various lifting height positions viking m mobile lift gives a flexibility for most lifting situations such as lifting to and from wheelchair, bed, toilet and floor.Horizontal lifting can also be performed in combination with the liko¿ octostretch¿ accessory.The hillrom service technician inspected the lift and found the fitting that attaches the sling bar to bottom of the flexlink was grooved out.The sling bar fell off due to the metal breaking.Per information received from the hillrom service technician, the patient weighed approximately 260 lb and was being lifted into the shower from a shower chair.The patient fell approximately 2 feet on to the shower chair.There were no known injuries.The periodic inspection protocol for liko mobile lifts 3en371001 rev 5 (which describes yearly inspections of liko mobile lifts) states under section 6: - check that the unit rotates freely on its bearings.Make sure the sling bar does not rotate unevenly, wobble or the spinning stops due to high friction.- check that the sling bar is correctly fastened.- make sure there are no deformities in the attachment points (a).The instruction guide for viking m, 7en137107 rev.4, states under inspection and maintenance: for trouble-free use, certain details should be checked each day the lift is used: ¿ inspect the lift and check to make sure that there is no external damage.¿ check the sling bar attachment.The ifu further states: a periodic inspection of the lift should be carried out at least once per year.A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this lift.It is unknown if the facility performs preventative maintenance on their lifts.Per the information provided, there was no injury to the patient from the fall.However, it is likely the malfunction could contribute to a serious injury or death if it were to recur.Therefore, this complaint is considered a reportable malfunction.

• Brand Name: VIKING M
• 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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 15542249
• MDR Text Key: 301159983
• Report Number: 8030916-2022-00049
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 00887761981874
• UDI-Public: 010088776198187411180927
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2040045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/13/2022
• 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