MAUDE Adverse Event Report: LIKO AB LIKO M230; NON-AC POWERED PATIENT LIFT

Model Number	2050015
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/09/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Hillrom received a report from the account stating the slingbar had broken loose from the pivot attachment.The lift was located at the account.There was a patient on the lift and when the lift dropped to the floor, the patient did as well.The customer reported that during use of the liko lift, the sling bar broke loose from the pivot, the patient was over the bed and fell to the bed, and the sling bar struck the patient on the back of her hands causing bruising to the back of her hands.No hospital treatment was provided to the patient, the patient was evaluated and reported to be ok.This report was filed in our complaint handling system as complaint (b)(4).
Additional Manufacturer Narrative
Hillrom technician investigated the lift involved in the incident and concluded that the slingbar had broken loose from the pivot attachment.The patient was over the bed and fell to the bed, and the sling bar struck the patient on the back of her hands causing bruising to the back of her hands.No hospital treatment was provided to the patient, the patient was evaluated and reported to be ok.The slingbar pivot point is constructed in such a way as to prevent inadvertent detachment of the slingbar during normal usage.A periodic inspection as per periodic inspection for liko mobile lifts (3en371001 rev.4) must be performed at least once per year.This instruction for periodic inspection states together with pictorial description under section 6.Slingbar: check that the unit rotates freely on its bearings.Make sure the sling bar doesn¿t rotate unevenly, wobble or the spinning stops due to high friction (not applicable on sabina and rollon) make sure that both latches are mounted and fall back against the body of the sling bar check that the sling bar is correctly fastened make sure there are no deformities in the attachment points (a) a liko m220/m230: measure the area shown, make sure the gap not exceeds 3 mm (1/8 inch) a search of hillrom maintenance records shows that no preventive maintenance has been performed by hillrom.It is unknown if the facility performs its own preventive maintenance.No pm sticker was present during technician investigation.The liko lift is intended as an aid in lifting and transferring patients.The device ifu states before each lift ensure the lifting accessory (slingbar/sling) is properly attached to the lift, check the function of the latches, and the latches are intact, missing or damaged latches must always be replaced.In addition, before lifting always make sure that the slings strap loops are correctly connected to the sling bar hooks, check that all suspension loops have the same length, are at an equal height when they are stretched prior to lifting the patient from the underlying surface.A bruise/contusion is an injury to tissues with skin discoloration and without breakage of skin.Blood from the broken vessels accumulates in surrounding tissues, which may produce pain, swelling, tenderness, and discoloration of the skin.Most bruises/contusions heal without treatment, cold compresses may reduce bleeding if applied immediately after the injury, and may reduce swelling, discoloration, and pain.Although the reported event did not result in serious injury, hillrom is conservatively reporting this event due to the fall.

• Brand Name: LIKO M230
• Common Device Name: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan ; SW
• MDR Report Key: 11785782
• Report Number: 8030916-2021-00019
• Device Sequence Number: 847627
• Product Code: FSA
• UDI-Device Identifier: 00887761981904
• UDI-Public: 010088776198190411191025
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 2050015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other