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

Model Number 2050010

Device Problem Device Slipped (1584)

Patient Problem Bone Fracture(s) (1870)

Event Date 02/11/2019

Event Type  Injury  

Manufacturer Narrative

The account did not provide any information regarding treatment.The liko lift was used in combination with a non-liko sling.Return of the lift has been requested for manufacturers evaluation.No further information is available on the repair of the lift at this time.The investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating the lift arm slid down twice during a lift from bath to bathing chair.The lift was located at the account at the time of the incident.The patient fell with the hip on the hard edge of the stretcher and broke the neck of his thighbone on both sides(femoral neck fracture).This report was filed in our complaint handling system as (b)(4).

Event Description

Hill-rom received a report from the account stating the lift arm slid down twice during a lift from bath to bathing chair.The lift was located at the account at the time of the incident.The patient fell with the hip on the hard edge of the stretcher and broke the neck of his thighbone on both sides (femoral neck fracture).This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

A hip fracture is a break in the upper quarter of the femur (thigh) bone.The extent of the break depends on the forces that are involved.Treatment for hip fractures usually involves a combination of surgery, rehabilitation and medication.The type of surgery used is primarily based on the bones and soft tissues affected or on the level of the fracture.Although details regarding the patient's medical history and treatment for the hip fracture was not provided, surgery is almost always required and therefore meets the definition of a serious injury.Hill-rom sales representative and technician visited the site but were not allowed to see the lift and the lift has not been returned to manufacturer for evaluation.Lift had been tested by non hill-rom external provider 07-11-2018.Hill-rom has never received any allegation of similar events for this mobile lift model.In the instruction guide under safety instructions it is stated: before using, make sure that: the lift is assembled in accordance with the assembly instructions; the lifting accessories are properly attached to the lift; charge the batteries for at least 6 hours; you have read the instruction guides for the lift and lifting accessories; personnel using the lift are informed of the correct operation and use of the lift.Before lifting, always make sure that: the lifting accessories are not damaged; the lifting accessories are correctly attached to the lift; the lifting accessories hang vertically and can move freely; the lifting accessories are selected appropriately, in terms of type, size, material and design, with regard to the patient¿s needs; the lifting accessories are correctly and safely applied to the patient in order to prevent injuries; the sling bar latches are intact.Missing or damaged latches must always be replaced with new ones; the sling¿s strap loops are correctly connected to the sling bar hooks when the sling straps are stretched up but before the patient is lifted from the underlying surface.

• Brand Name: LIKO M220
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• MDR Report Key: 8420007
• MDR Text Key: 138772445
• Report Number: 8030916-2019-00015
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2050010
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 76