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

Model Number	3121001
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided pictures of the broken composite sling bar hook.The picture confirms a fracture in the composite hook.An hillrom technician inspected the lift and found no other malfunction.The slingbar was replaced for the customer.The universal slingbar can be used in combination with liko slings that attaches to the sling bar using sling loops.Liko´s universal sling bars are with two assembly options, fixed assembly or with quick release hook.Hillrom investigation on previous similar cases concludes that the universal slingbar will not break if it is used as intended.The universal slingbar can hold the load it is designed for if the load is applied according to instruction for use.Tests demonstrate that the composite hooks on the universal slingbar can withstand more than 780 kg load until breakage.Our investigation further shows that the breakage of the composite hook can occur at lower weight if the load is not centered, the load is applied in only one hook or the load is not applied inside the hook as intended.In the instruction for use for universal sling bars (7en160185 rev 5), the safety instruction section states: before lifting, always make sure that the slings strap loops are correctly fastened to the sling bar hooks when the sling strap is extended, but before the patient is lifted from the underlying surface.For safety, load must be applied to all sling bar hooks on the sling bar during the lift! it is also documented in the instruction for use, both in text and in pictorial illustrations, how the loops of the sling shall be applied to the slingbar and how the sling bar shall be leveled.Although there was no patient injury associated with the reported event, the report of the sling bar hook breaking during patient lift could contribute to a serious injury or death, if the malfunction were to recur.Therefore, hillrom considers this complaint a reportable malfunction.
Event or Problem Description
It was reported that one of the slingbars hooks broke during a patient transfer from the bed to the chair.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This report was filed in our complaint handling system as (b)(4).

• Brand Name: LIKORALL 200
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16681251
• Report Number: 8030916-2023-00028
• Device Sequence Number: 12750119
• Product Code: FSA
• UDI-Device Identifier: 00887761981911
• UDI-Public: 010088776198191111210508
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/05/2023

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: 3121001
• 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: 03/21/2023
• Initial Report FDA Received Date: 04/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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