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

Model Number 2050015

Device Problems Smoking (1585); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician evaluated the product and found the charging cable was damaged.Liko lifts should be periodically inspected at least once per year.In the periodic inspection for mobile lifts, 3en371001 rev.4 it is stated: battery, cables and charging: verify that all cables are properly inserted.Re-insert if uncertain.Verify battery charge by inspecting the charger indicator.Check cables and connectors for damage or wear.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.Hill-rom replaced the faulty cable and the product functioned as designed.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating lift was sparking and smoke was coming out.The lift was located at the account at the time of the incident.There was no patient or user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: LIKO M230
• 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: 8549235
• MDR Text Key: 143426985
• Report Number: 8030916-2019-00024
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 03/29/2019

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
• Device Model Number: 2050015
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/25/2014
• 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