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

Model Number 2040003

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/22/2017

Event Type  malfunction  

Manufacturer Narrative

During inspection of the device, the hill-rom technician found that the customer had bored out one of the front forks and installed a substitute caster.The substitute caster was not an original liko spare part.The technician also found the front casters, locking mechanisms, front forks, front fork covers, safety latches, and assembly bolts needed to be replaced.In the periodic inspection for mobile lifts, the following shall be checked: roll the lift along the floor.Check to ensure that all wheels roll and turn freely.Make sure the wheels are fastened.Lock the brakes, make sure the wheels do not turn and the housing does not swivel when the lift is pushed.There should not be any play between the fork and the wheel nut.The instruction guide for viking xl (7en135104-04) states that repairs and maintenance may only be carried out by personnel authorized by liko using original liko spare parts.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.The hill-rom technician installed new front casters, locking mechanisms, front forks, front fork covers, safety latches, and assembly bolts to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the front caster came off during a patient lift.The lift was located in the patient area at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: VIKING XL
• 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: jesper lundstrom ; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 6646720
• MDR Text Key: 77842155
• Report Number: 8030916-2017-00029
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Service Personnel
• Type of Report: Initial
• Report Date: 05/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other Caregivers
• Device Model Number: 2040003
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/22/2017
• Initial Date FDA Received: 06/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2007
• 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