MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SOLO HIGH BACK SLING; LIFT PATIENT NON AC POWERED

Model Number	3525915
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Bone Fracture(s) (1870)
Date of Event	02/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported that the liko solo high back sling broke during a patient transfer.It was noted that the patient had fallen out of bed and needed to be lifted back into bed as they could not stand on their legs.The staff placed the sling and connected it to the lift, however, when the transfer was initiated, a loud bang was heard as the sling had broken at the seams.Fortunately, the patient was not too high above the floor, however, due to their weight, they fell hard on their shoulder region.The patient subsequently had an x-ray or ct scan of their shoulder (reporter could not remember), which showed a small fracture that had to be treated conservatively.
Additional Manufacturer Narrative
Solo highback sling is designed for adaptation to patients without the need for individual adjustments.Solo highback sling provides support for the entire body, and gives a slightly reclined sitting posture, which is appropriate for patients with poor torso stability.Solo highback sling is recommended for lifting to and from the bed, wheelchair or toilet.A shoulder fracture occurs when any of the three bones in the shoulder joint (humerus, clavicle, or scapula) break.Common causes include trauma from falls, accidents, or sports injuries.Treatment may involve wearing a brace or sling, and surgery may be necessary.In this event, it was reported that a patient sustained a shoulder fracture as a result of fall that occurred with a liko solo high back sling and required conservative treatment to preclude a permanent impairment of a body function or permanent damage to a body structure, concluding that a serious injury occurred.Additionally, the exact cause of the reported event is unknown, and a use error/misuse of the device cannot be excluded.During follow up with the customer, it was confirmed that the device has been discarded and is not available to be returned for investigation.Therefore a root cause of the reported issue can not be confirmed.However if the sling were to break at the seams during a patient transfer, it could lead to serious injury or death.Baxter is reporting this event.

• Brand Name: SOLO HIGH BACK 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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21642687
• Report Number: 8030916-2025-00054
• Device Sequence Number: 7574116
• Product Code: FSA
• UDI-Device Identifier: 00887761983403
• UDI-Public: (01)00887761983403
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• 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
• Report Date (Section B): 03/19/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 3525915
• Device Catalogue Number: 3525915-2
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2025
• Initial Report FDA Received Date: 03/19/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male