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

Model Number P2040006

Device Problems Component Missing (2306); Detachment of Device or Device Component (2907)

Patient Problem Bone Fracture(s) (1870)

Event Date 06/21/2018

Event Type  Injury  

Manufacturer Narrative

A hill-rom technician visited the account to perform the investigation and to evaluate the product that was involved in the reported incident.He was informed by the account that the device had been sent back to the rental company after the incident.Evaluation of the involved lift has therefore not been possible.In the instruction guide for vikings (7en138104), it is stated under safety instructions: before lifting, always make sure that: the sling bar latches are intact; missing or damaged latches must always be replaced.The sling's strap loops are correctly connected to the sling bar books when the sling strap is extended, but before the patient is lifted from the underlying surface.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 preventive maintenance on their lifts.It is of utmost importance that the sling strap loops are correctly connected to the sling bar hooks when preparing for patient transfer.If the sling strap loops are correctly connected, they will not detach from the sling bar hooks regardless if the sling bar latches are installed or not because the weight of the patient will keep the sling strap loops secured in place in the sling bar hooks.As per the safety instructions, always make sure before lifting that the sling's strap loops are correctly connected to the sling bar hooks when the sling strap is extended, but before the patient is lifted from the underlying surface.Based on this information, the most likely root cause is the accounts misapplication of the sling strap loop to the sling bar hook.

Event Description

Hill-rom received a report fi-om the account stating that during patient transfer, the sling loop came off the sling bar causing the patient to fall from the lift.The account informed the technician that the sling bar latches was missing from the sling bar when they received the product from the rental company.The lift was located at the account at the time of the incident.The patient sustained a fracture above his prosthetic knee, was hospitalized and required surgical intervention.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VIKING S
• 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
• Manufacturer Contact: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 7833963
• MDR Text Key: 118801835
• Report Number: 8030916-2018-00044
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/30/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: P2040006
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other