MAUDE Adverse Event Report: LIKO AB VIKING M, WHEEL 75/75; NON-AC POWERED PATIENT LIFT

Model Number P2040005

Device Problems Detachment Of Device Component (1104); Component Falling (1105)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/15/2016

Event Type  malfunction  

Manufacturer Narrative

Upon inspection, the hill-rom technician found the customer was not using the red quick-release hook correctly.This incident was therefore caused by user error.In the instruction guide for universal slingbars (7en160185), the care and maintenance section states: when using a quick-release hook system, check that the quick-release hook is correctly fastened to the lift and the slingbar.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 technician in-serviced the account on the proper usage of the quick-release hook.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the red quick-release hook on the slingbar snapped off and the slingbar landed on the patient during a patient transfer.There was no patient or user injury reported.The lift was located in the patient room at the account at the time of the incident.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: VIKING M, WHEEL 75/75
• 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: nazanin bitaraf ; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 5551749
• MDR Text Key: 42614478
• Report Number: 8030916-2016-00045
• 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: Other
• Type of Report: Initial
• Report Date: 03/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P2040005
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/28/1995
• 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