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 Codes	Abrasion (1689); Erythema (1840); Laceration(s) (1946)
Date of Event	02/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multirall¿ 200 overhead lift is a general-purpose lift with the intended use in: health care, intensive care and rehabilitation.Multirall 200 overhead lift is easy to move between facilities and useful for room-to-room transitions.Multirall¿ 200 overhead lift can be mounted to the rail carriage in two different ways, mounted with the lift strap under the lift unit or mounted with the lift strap above the lift unit.Intended for use in all common lift and transfer situations, for example, between bed/wheelchair, to/ from floor, toilet visits, gait training, and for horizontal lifts with stretchers.A search of the baxter maintenance records showed baxter performed preventative maintenance on this device in dec 18, 2024.It is unknown if the facility performed any other preventative maintenance on this device.Upon inspection, baxter technician found that traces of creases were observed on the lift¿s straps.It was determined that the event was likely due to a fold in the lift strap that was inadvertently created by the user.Additional training and a clear guide to good use was provided to the customer.Based on this information, no further actions are required at this time.Although there was no reported injury with this event, if the report of a patient fall due to lift strap unspooled were to recurred, it could potentially cause serious injury or death.Therefore baxter is reporting this event.
Event or Problem Description
On (b)(6) had a mobile lift motor strap suddenly unspooled, causing a resident fall.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.

• 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: 24595660
• Report Number: 8030916-2026-00027
• Device Sequence Number: 21006971
• 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
• Report Date (Section B): 03/13/2026

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: 02/25/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2026
• Initial Report FDA Received Date: 03/13/2026
• 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
• Patient Sex: Unknown