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

Model Number	3122012
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 8030916-2022-00007
• Device Sequence Number: 4870686
• Product Code: FSA
• UDI-Device Identifier: 00887761979468
• UDI-Public: 010088776197946811211117
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2022
• Initial Report FDA Received Date: 02/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/12/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown