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

Model Number	3525916-2
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the baxter technician found the sling was tore along or near the seam.The tear was about 1.5 feet to center of sling.The baxter technician was unable to determine the cause of the issue, the sling is disposable and it is unknown how many times it was used.The solo highback sling instructions for use 7en160179, states the following under care and inspection: solo highback sling is a disposable item intended for individual use only.The solo highback sling should no longer be used: if it is soiled or if it is suspected of being contaminated.If it is damaged.The baxter technician replaced the sling to resolve the issue.This issue would be likely to cause or contribute to a death or serious injury if this were to recur.
Event or Problem Description
A customer contacted technical service to report that the solo high back sling tore at the seams during a patient lift resulting in a fall.The customer stated the patient was not injured.It was additionally reported that this sling was being used with a non liko lift,this occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.The device was requested for service/inspection by baxter.
Additional Manufacturer Narrative
The service technician was contacted for additional information about the event.The sling was requested for return to lulea but the customer did not want to release it.The service technician provided pictures of the sling, and it was observed that the do not use-symbol was visible.When the sling is new, the top layer on the label will display the do not wash-symbol.If the sling is washed, the top layer of the label disappears and the do not use-symbol will appear, which is an indication to not use the sling.Based on the information that has been provided, the likely cause is that the customer has washed the sling (which weakens the fabric) and then used it when the do not use-symbol was visible, which is contrary to what is described in the ifu.
Event or Problem Description
A customer contacted technical service to report that the solo high back sling tore at the seams during a patient lift resulting in a fall.The customer stated the patient was not injured.It was additionally reported that this sling was being used with a non liko lift,this occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.The device was requested for service/inspection by baxter.

• Brand Name: SOLO 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: 21983511
• Report Number: 8030916-2025-00070
• Device Sequence Number: 4312176
• Product Code: FSA
• UDI-Device Identifier: 00887761983427
• UDI-Public: (01)00887761983427
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/15/2025

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: 3525916-2
• Device Catalogue Number: 3525916-2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 07/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown