MAUDE Adverse Event Report: LIKO AB LIKORALL 242 S R2R, WHITE; NON-AC POWERED PATIENT LIFT

Model Number 3122012

Device Problem Component Missing (2306)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/07/2022

Event Type  malfunction  

Manufacturer Narrative

The likorall 242 s r2r was used with a universal slingbar 450.When the patient was about to be lifted from a chair.The lift was operated upwards and the slingbar came away.The patient remained in the chair when the lift went up.A hillrom service technician has inspected the slingbar.It was found that locking screws was missing.The locking screws has not been assembled in manufacturing.The locking screws shall prevent the bolt and the nut holding the slingbar together from unthreading.The missing locking screws resulted in that the nut was turned when maneuvering the sling bar, until the nut separated from the bolt which caused the slingbar to separate in two parts.The periodic inspection form for overhead lifts (3en191001 rev.2), states through words and pictorial description that the following should be inspected on the slingbar at least annually: check that the unit rotates freely on its bearings.Make sure the sling bar doesn¿t rotate unevenly, wobble or the spinning stops due to high friction.Make sure that both latches are mounted and fall back against the body of the sling bar.Check that the sling bar is correctly fastened.Make sure there are no deformities in the attachment points (a).Further, the instruction for use for likorall 242 (7en120115 rev.11) state: before lifting, always make sure that: the lifting accessories are not damaged; the lifting accessory is properly attached to the lift; the lifting accessory hang vertically and can move freely.The slingbar has been taken out of use and was replaced.At the request of the account all their slingbars were inspected, 18 devices, without finding any other deviating devices.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating that a patient had fallen from the lift.The lift was located at the account at the time of the incident.There was no patient or user injury.This report was filed in our complaint handling system as (b)(4).

• Brand Name: LIKORALL 242 S R2R, WHITE
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan 975 9 2; SW 975 92
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13415037
• MDR Text Key: 287269945
• Report Number: 8030916-2022-00007
• Device Sequence Number: 1
• Product Code: FSA
• UDI-Device Identifier: 00887761979468
• UDI-Public: 010088776197946811211117
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 3122012
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/12/2021
• 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