MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 242 S; LIFT PATIENT NON AC POWERED

Model Number	3122010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, it was confirmed that there was a break in the composite hook part of the slingbar.The field service technician replaced the slingbar to resolve the alleged issue.The universal slingbar can be used in combination with liko slings that attaches to the sling bar using sling loops.Likos universal sling bars are with two assembly options, fixed assembly or with quick-release hook.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 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 serious injury associated with the reported event, if the sling bar hook were to break during patient lift, it could contribute to a serious injury or death.Therefore, baxter considers this complaint a reportable malfunction.
Event or Problem Description
A other health care professional contacted technical service to report that the likorall 242 s, composite hook broke during a patient transfer.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: LIKORALL 242 S
• Common Device Name: LIFT PATIENT NON AC POWERED
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): LIKO AB; nedre vagen 100; lulea 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20736550
• Report Number: 8030916-2024-00104
• Device Sequence Number: 8372246
• Product Code: FSA
• UDI-Device Identifier: 00887761979819
• UDI-Public: (01)00887761979819
• 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: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 11/20/2024

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
• Operator of Device: Other
• Device Model Number: 3122010
• Device Catalogue Number: 3122010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 11/20/2024
• 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