MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKO ORIGINAL HIGHBACK SLING; LIFT PATIENT NON AC POWERED

Model Number	35210305
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Liko original highback sling is a basic model which is designed to adapt to the patient without individual adjustments.It provides for a slightly semi-reclined sitting posture and support for the entire body, which is good for patients with reduced torso stability.The original highback sling is also recommended for lifting to or from the floor, since it provides a comfortable head support both in sitting and in lying position.The harness has been requested to be returned for inspection.Investigation into the reported incident is currently on-going.A supplemental report will be submitted with investigation findings upon completion.
Event or Problem Description
A other health care professional contacted technical service to report that orig hb sling 200 had an issue, staff would move patient from tipping board to wheelchair.When the staff applied the harness and lifts the patient, the harness breaks at the seam towards the edge and teared up.Staff act quickly and transfer the patient to the wheelchair and take the lifting harness out of use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The sling was returned for analysis where it was determined that it was in an overall good condition besides the binding seam damaged at the upper strap loop.The sling had a torn seam in the binding/edging at the upper strap loop.Both the 2-needle edging seams and the reinforcement seam was broken.The strap itself was intact and not unusually worn, the fabric was in good condition and not worn.If sling breaks during lifting, the lifting movement can continue and be completed without safety risk for the patient since all 4 sling loops are intact.Attempts to recreate user conditions reported by customer have been performed but not succeeded to cause the patient falling.Lifting safely with this kind of sling failure was still possible to do.The investigation concluded that this issue would be unlikely to cause or contribute to a death or serious injury if this were to recur.Baxter does not consider this to be a reportable malfunction.
Event or Problem Description
A other health care professional contacted technical service to report that orig hb sling 200 had an issue, staff would move patient from tipping board to wheelchair.When the staff applied the harness and lifts the patient, the harness breaks at the seam towards the edge and teared up.Staff act quickly and transfer the patient to the wheelchair and take the lifting harness out of use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• Brand Name: LIKO ORIGINAL HIGHBACK SLING
• 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 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21479291
• Report Number: 8030916-2025-00039
• Device Sequence Number: 18246189
• Product Code: FSA
• UDI-Device Identifier: 00887761983304
• UDI-Public: (01)00887761983304
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2025

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
• Device Model Number: 35210305
• Device Catalogue Number: 35210305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2025
• Supplement Date Received by Manufacturer: 06/25/2025
• Initial Report FDA Received Date: 02/27/2025
• Supplement Report FDA Received Date: 06/27/2025
• 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: Male