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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer provided a video of the liftpants which showed one of the straps had come apart from the seam.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.Although there was no adverse event associated with this malfunction and the issue was found during testing, if the strap of the liftpants were to detach during a patient transfer it could lead to a serious injury or death therefore baxter is reporting this device malfunction.
Event or Problem Description
A other health care professional contacted technical service to report that the liftpants 92 pes mesh xl had an issue, the lift pants have been inspected during and have failed.The inspector stated the strap was testedat approx.100kg, and the strap came apart this occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.

• 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: 21166908
• Report Number: 8030916-2025-00003
• Device Sequence Number: 18526268
• 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): 01/16/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2024
• 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: 01/16/2025
• 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