MAUDE Adverse Event Report: LIKO AB SABINA II EE BASIC; NON-AC POWERED PATIENT LIFT

Model Number 2020003

Device Problem Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/13/2017

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the knee rest came off due to a defective mast.In the instruction guide, 7en155103 it is stated in the safety instructions that before lifting always make sure that the lifting accessories are not damaged.It is also stated in the care and maintenance instructions that each day the lift is used, it shall be inspected to make sure that there is no external damage.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 customer replaced the mast 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 knee rest came off the lift.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: SABINA II EE BASIC
• 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: 6399136
• MDR Text Key: 70006014
• Report Number: 8030916-2017-00008
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 02/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2020003
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/13/2017
• Initial Date FDA Received: 03/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2012
• 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