MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MULTIRALL OVERHEAD LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number	3130001
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	02/24/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter address: (b)(6).The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter recieved a report when a caregiver pushed the lift to remove it from their working area but pushed it too hard and made it swing, and when it came back, it hit them in the temple.The caregiver was admitted to the emergency department for a suspected head injury and was given a one-week medical leave.Additionally, no initial device malfunction was reported.No further information was available at the time of this report.
Additional Manufacturer Narrative
Investigation indicated the user did not follow instructions and/or labeling, resulting in the accident.This issue is determined to be caused by user error.Baxter offered customer training but the customer confirmed it is not needed since they already booked training on april regardless of the event.Should additional relevant information become available, a supplemental report will be submitted.The instructions for use warning the user to make sure of the following before using the device: the lift is assembled in accordance with the assembly instructions.The lifting accessories are properly attached to the lift.The batteries have been charged for at least 8 hours.You have read the instruction for use for the lift and lifting accessories personnel using the lift are informed of the correct use of the lift and lifting accessories.The lifting accessory is selected appropriately, in terms of type, size, material and design with regard to the patient¿s needs.

• Brand Name: MULTIRALL OVERHEAD LIFT
• 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, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24665109
• Report Number: 8030916-2026-00029
• Device Sequence Number: 13083744
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 05/19/2026

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?: No
• Operator of Device: Other
• Device Model Number: 3130001
• Device Catalogue Number: 3130001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2026
• Supplement Date Received by Manufacturer: 05/05/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 05/19/2026
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown