MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKO LIFTPANTS; LIFT PATIENT NON AC POWERED

Model Number	3592327
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Liko liftpants sling facilitate safe and secure standing- and gait training for patients with poor balance and leg function, giving them the confidence to take new steps.It is essential that the patient is able to bear weight on their legs.Liftpants sling enable freedom of movement, while relieving some of the burden of body weight.They lift safely, allowing the patient to move on his/her own without the risk of falling.During training, the lift is ready to take all the weight, so the patient and caregiver can devote all their attention to training without having to worry about the consequences of a wrong step.The device was not returned for inspection, therefore a root case of the reported incident could not be determined.The instructions for use 7en160170 states the following: check the sling before each use.Check the following points with regard to wear and damage: fabric straps seams loops although there was no injury reported and the root cause of the malfunction could not be investigated, if the sling pants stitching were to come apart during a patient lift on a load bearing seam it could lead to serious injury or death therefore, baxter is reporting this incident.
Event or Problem Description
A other health care professional contacted technical service to report that liftpants 92 pes mesh xl, had an issue, during use with a patient the stitching became undone and caused the patient to drop about 6 inches back onto the chair they were lifted from.No injury was reported.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: LIKO LIFTPANTS
• 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: 21151908
• Report Number: 8030916-2025-00002
• Device Sequence Number: 9088315
• Product Code: FSA
• UDI-Device Identifier: 00887761984028
• UDI-Public: (01)00887761984028
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 3592327
• Device Catalogue Number: 3592327
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/20/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown