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

Model Number	3130001
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report that multirall 200 had strap falling on patient.This occurred during patient use.It was reported that there was not patient/user injury or medical intervention with this event.
Additional Manufacturer Narrative
No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
The service technician inspected the lift and found that the pin was missing.The cause of the issue was user error.The technician resolved the issue by attaching a new pin.Investigation indicated the user did not follow instructions and/or labeling, resulting in the accident.The ifu of the device warning the patient to before use, make sure that: the lift is assembled in accordance with the assembly instructions.The lifting accessories are properly attached to the lift.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.The sling bar latches are intact; missing or damaged latches must always be replaced the sling¿s strap loops are correctly connected to the sling bar hooks when the sling straps are extended, but before the patient is lifted from the underlying surface.

• 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: 25192445
• Report Number: 8030916-2026-00060
• Device Sequence Number: 13002764
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284(11)240131
• 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): 06/22/2026

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
• 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: 04/24/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/21/2026
• Supplement Date Received by Manufacturer: 05/28/2026
• Initial Report FDA Received Date: 05/15/2026
• Supplement Report FDA Received Date: 06/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown