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

Model Number	3130001
Medical Device Problem Code	Device Fell (4014)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	04/13/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An inspection of the device performed by a baxter technician noted that no malfunction was identified.The reported event could not be replicated and was attributed to a possible incorrect attachment of the lift to the rail.Upon inspection, baxter technician ran a function test on device and rail.The baxter technician thoroughly inspected the lift and was unable to duplicate the reported issue.The lift functioned as designed.However, if the reported event of a engine falling were to recur, it would be likely to cause or contribute to death or serious injury, therefore baxter considers this event reportable.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 bed in sep 16, 2025.It is unknown if the facility performed any other preventative maintenance on this bed.
Event or Problem Description
Baxter received a report that multirall had engine fall.The strap detached from the rail without the patient present, medical staff intervened to secure the motor mid-air, but the attachment subsequently fell onto the patient.The process step during which this occurred was during use.There was not patient injury.

• 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: 25117340
• Report Number: 8030916-2026-00057
• Device Sequence Number: 16020377
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284(11)221015
• 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): 05/07/2026

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: 04/15/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2026
• Initial Report FDA Received Date: 05/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2022
• 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: A
• Patient Sequence Number: 1
• Patient Sex: Unknown