MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION UNIVERSAL SLINGB 450 QRH; LIFT PATIENT NON AC POWERED

Model Number	3156085
Medical Device Problem Code	Fracture (1260)
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
During follow up, it was confirmed that the incident occurred during a weight test and no patient was involved.It was reported after the weight cart was put on the slingbar and picked up about 1" off the ground, the slingbar hook snapped.The slingbar was replaced for the customer.Universal slingbar can be used in combination with liko slings that attaches to the sling bar using sling loops.Liko´s universal sling bars are with two assembly options, fixed assembly or with quick-release hook.Although there was no patient involvement and the incident occurred during testing, if the reported event were to recur, it could lead to serious injury or death therefore, baxter is reporting this event.
Event or Problem Description
A other health care professional contacted technical service to report that the universal slingb 450 qrh, had an issue, when installers were preforming a weight test of a system, when attempting to pick up the 550lb load the sling bar broke.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.

• Brand Name: UNIVERSAL SLINGB 450 QRH
• 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: 22025500
• Report Number: 8030916-2025-00075
• Device Sequence Number: 7266720
• Product Code: FSA
• UDI-Device Identifier: 00887761982444
• UDI-Public: (01)00887761982444
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/15/2025

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: 3156085
• Device Catalogue Number: 3156085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 05/15/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown