MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MULTIRALL 200; 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	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The multirall 200 overhead lift is a general-purpose lift 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.It is intended to be used in health care, intensive care, and rehabilitation facilities.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.The device can also be used with an accessory extension belt.The device instructions for use (ifu) state the following: install the multirall overhead lift by placing the top connector directly into the carriage hook.Check that the unit is resting securely at the bottom of the hook before applying a load or lifting a patient.Before lifting, always make sure that lifting accessories are correctly applied to the lift.The inspection of the device performed by a baxter technician found the multirall device to be working as designed and noted that use error likely contributed to the root cause; however, the investigation is still ongoing.It was suspected by the technician that the person who used the lift strap removed the system from the buckle and did not know how to put it back in place correctly.In this event, the customer confirmed the patient did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes no serious injury occurred.At this time, the cause of the event is unable to be determined and use error cannot be excluded.The investigation is ongoing and any additional information will be provided in a final report.If a similar event were to recur (the extension belt comes undone and engine falls), it would be likely to lead to a serious injury or death.
Event or Problem Description
It was reported that during the use of the multirall 200, the extension belt came undone, and the engine fell on the patients¿ abdomen.No injury or medical intervention was reported.
Event or Problem Description
It was reported that during the use of the multirall 200, the extension belt came undone, and the engine fell on the patients¿ abdomen.No injury or medical intervention was reported.
Additional Manufacturer Narrative
The multirall 200 overhead lift is a general-purpose lift 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.It is intended to be used in health care, intensive care, and rehabilitation facilities.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.The device can also be used with an accessory extension belt.The device instructions for use (ifu) state the following: install the multirall overhead lift by placing the top connector directly into the carriage hook.Check that the unit is resting securely at the bottom of the hook before applying a load or lifting a patient.Before lifting, always make sure that lifting accessories are correctly applied to the lift.The technician provided additional information about the event.The technician confirmed that the extension belt had no signs of tear or damages on the seams.The marks from where the extension belt was originally installed to the q-link ii were visible.The technician suspected that the person who used the extension belt removed it from the q-link ii and did not know how to put it back in place correctly.Based on the provided information, the likely cause is that the person who used the extension belt removed it from the q-link ii and did not know how to put it back in place correctly.Then when the lift was used, the extension belt came loose from the q-link ii and the lift fell on the patient's abdomen.In this event, the customer confirmed the patient did not sustain permanent impairment of a body function or permanent damage to a body structure and did not require medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes no serious injury occurred.If a similar event were to recur (the extension belt comes undone and engine falls), it would be likely to lead to a serious injury or death.

• Brand Name: MULTIRALL 200
• 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: 22837658
• Report Number: 8030916-2025-00099
• Device Sequence Number: 9548912
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284(11)240718
• 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): 10/20/2025

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/23/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 08/19/2025
• Supplement Report FDA Received Date: 10/20/2025
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown