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

Model Number 2040015

Device Problem Detachment Of Device Component (1104)

Patient Problem Fall (1848)

Event Date 02/15/2017

Event Type  Injury  

Manufacturer Narrative

Upon inspection, the hill-rom technician noted that the red plastic on the slingbar quick release hook was damaged and that the hook itself was abnormally worn.He also noted that the sling used was not a liko sling.The red plastic quick release hook lock is used only as a guide to see if the hook is positioned correctly.It is not a weight bearing part in the construction and is not intended to take any load in the lift of the patient.If it breaks, it is an indication that the hook is positioned incorrectly causing it to break when it bears weight during the lifting of the patient.The abnormal wear on the hook indicates the part has also been incorrectly positioned in prior lifts.In the user manual for the mobile device involved in this incident, it is stated under the safety instructions: "before lifting, always make sure that the lifting accessories are not damaged and the lifting accessory is correctly attached to the lift." this would apply to the red plastic quick release hook.The user manual also states "using lifting accessories other than those approved can entail a risk." 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 account manager instructed the account to ensure all staff checks the condition of their lifts and accessories before each use.The account manager also instructed the account to only use a liko brand sling.The hill-rom technician replaced the damaged slingbar.The account has returned the quick release hook to hill-rom for further analysis.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating that while weighing a patient, the slingbar dislodged from the lift causing the patient to fall on her back onto the floor from approximately 1 meter.The patient was sent to the emergency room for x-rays and no fracture was detected, so the patient was transferred back to the account.The lift was located at the account at the time of the incident.This report was filed in our complaint system as complaint #(b)(4).

• Brand Name: VIKING M WIRELESS
• 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: 6368435
• MDR Text Key: 68749157
• Report Number: 8030916-2017-00005
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 02/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other Caregivers
• Device Model Number: 2040015
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/01/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2010
• 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
• Patient Outcome(s): Hospitalization
• Patient Age: 80 YR
• Patient Weight: 94