MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION LIKORALL 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	03/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional contacted technical service to report that the multirall 200 lift fell.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The baxter technician inspected the motor and found damage to the cover as a result of the fall.It was additionally confirmed there was no patient injury as a result of the incident and that the event was likely caused by incorrect installation of the motor.Additional information has been requested regarding the reported event and the investigation is currently on going.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A other health care professional contacted technical service to report that the multirall 200 lift fell.The process step during which this occurred was unknown.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
During follow up it was confirmed the motor fell during installation, it was reported that the motor was incorrectly installed onto the hook during set up.It was also reported that extension straps were used due to the facility having very high ceilings which made it difficult to check that the motor was correctly attached to the hook during installation.The customer also reported the same issue had occurred with 2 other motors during the installation.There was no patient involvement.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.There was no device malfunction or patient involvement, the incident was caused by use error of incorrect installation.If the reported event were to recur, it would be unlikely to cause injury or death.

• Brand Name: LIKORALL 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 97592 ; SW 97592
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21707770
• Report Number: 8030916-2025-00058
• Device Sequence Number: 10072420
• 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): 05/21/2025

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: 3130001
• Device Catalogue Number: 3130001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 05/20/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/21/2025
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown