MAUDE Adverse Event Report: LIKO AB MULTIRALL 200; NON-AC POWERED PATIENT LIFT

Model Number 3130001

Device Problems Component Falling (1105); Misassembled (1398)

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

According to the account, the root cause of the detachment is that they incorrectly installed the multirall.The q-link was not properly attached in the s65 carriage.The account has also stated that they did not ensure the device was properly positioned before proceeding with the transfer.According to 7se125213 rev.02 "extension arm multirall", hill-rom states that the user shall make sure that the q-link is properly positioned into the carriage hook and that the lift strap is safely attached to the hook.The multirall can be mounted to the rail system in two different ways, depending on the intended use.When mounted with the lift strap under the lift unit, it works as a normal overhead lift.When mounted with the lift strap above the lift unit, multirall becomes a flexible room-to-room lift that can be used for transfers of patients between different rail systems in different rooms without requiring openings over doorways.In this case, the lift strap was mounted above the lift unit.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.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating a q-link was not correctly positioned into the s65-carriage causing the multirall to fall down onto the patient's forehead.The device was located at the account at the time the incident.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: MULTIRALL 200
• Type of Device: NON-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: 5736654
• MDR Text Key: 48521973
• Report Number: 8030916-2016-00079
• 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: 05/31/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3130001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 05/31/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2016
• 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