MAUDE Adverse Event Report: LIKO AB LIKORALL 250 ES, WHITE; LIFT, PATIENT, NON-AC-POWERED

Model Number	3122502
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided a picture of the broken composite sling bar hook, displaying a complete fracture in the composite hook.It was also reported that the broken components were replaced before the lift inspection.When inspected, the lift was found to be working as intended.The most probable cause for the composite hook to break is the load being applied asymmetrically on only one side of the sling bar.Tests performed on universal sling bars have shown that when the load is applied to both sling bar hooks, as per the intended use, the composite hook can withstand > 780 kg before breakage.In the instruction for use for universal sling bars (7en160185 rev 5), the safety instruction section states: before lifting, always make sure that the sling¿s 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! 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
The customer reported that while attempting to move a patient using the likorall 250 device, the device's sling bar composite hook broke off the sling bar.There was no injury associated with this event.This report was filed in our complaint handling system as (b)(4).

• Brand Name: LIKORALL 250 ES, WHITE
• 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: 15173184
• Report Number: 8030916-2022-00041
• Device Sequence Number: 17423645
• Product Code: FSA
• UDI-Device Identifier: 00887761979505
• UDI-Public: 010088776197950511210909
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 08/05/2022

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: 3122502
• 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: 07/26/2022
• Initial Report FDA Received Date: 08/05/2022
• 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