MAUDE Adverse Event Report: LIKO AB VARDLIFT 2300; AC-POWERED PATIENT LIFT

Model Number VÅRDLIFT 2300

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/09/2016

Event Type  malfunction  

Manufacturer Narrative

When the technician investigated the liko masterlift 2300, he found the lift strap axle was broken due to 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.Since the product is beyond its expected life, it will be scrapped.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating that during a patient transfer, the lift strap from a liko masterlift 2300 released about 50-60 cm and the patient fell into the wheelchair.The lift was located in a patient room at the account at the time of the allegation.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: VARDLIFT 2300
• Type of Device: AC-POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vägen 100; luleå, norrbottens län 975 9 2; SW 975 92
• Manufacturer Contact: marlene bjurman ; nedre vägen 100; luleå, norrbottens län 975 9-2 ; SW 975 92
• MDR Report Key: 5489815
• MDR Text Key: 40255015
• Report Number: 8030916-2016-00033
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/09/2016

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: No Information
• Device Model Number: VÅRDLIFT 2300
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/09/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/1994
• 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