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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	11/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a caregiver sustained an injury when transferring a patient in a multirall overhead lift.After the caregiver had provided nursing care to a resident, the caregiver wanted to transfer another resident; however, the mobile patient lift wasn't working because the battery wasn't properly secured.Instead of using the other mobile patient lift, the caregiver took the lift from the room across the hall, and since the rail heights were different, the strap was short, making it difficult to attach the lifting rod.This resulted in the detachment of the lift.The caregiver was able to save the resident who was already in the transfer net.The patient was not harmed; however, it was noted that the caregiver required sick leave due to cervical, shoulder, back, and left arm injury.No further information was available at the time of this report.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).H11: the actual device could not be returned; however, a baxter technician performed an on-site evaluation of the device.An inspection of the device performed by the technician noted that no malfunction was identified; however, further investigation is ongoing.The investigation is currently ongoing, a final report will be submitted upon completion.
Additional Manufacturer Narrative
Additional information h6 and h11.H11: the device was evaluated onsite by a baxter qualified technician.Additional information was obtained by the technician regarding the event.The lift had a crack in the cover after the fall.The lift strap was equipped with q-link ii, which was attached to the carriage in the rail.The rail was equipped with a s65 carriage hook.The caregiver was installing the lift with the pole (extension arm).When the caregiver released the lift, the q-link ii was not attached to the s65 carriage hook, causing the lift to fall to the floor.Based on the information that has been provided, it is reasonable to conclude that when the lift was installed by the caregiver, the q-link ii on the lift strap was not properly attached to the s65 carriage hook.Since the q-link ii was not securely attached to the s65 carriage hook, this caused the lift to detach and fall.Therefore, this issue is determined to be caused by user error.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.Should additional relevant information become available, a supplemental report will be submitted.

• 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 ; 2242702068
• MDR Report Key: 23881582
• Report Number: 8030916-2025-00149
• Device Sequence Number: 9623031
• Product Code: FSA
• UDI-Device Identifier: 00887761982284
• UDI-Public: (01)00887761982284(11)240205
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 3130001
• Device Catalogue Number: 3130001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Supplement Date Received by Manufacturer: 02/16/2026
• Initial Report FDA Received Date: 12/23/2025
• Supplement Report FDA Received Date: 03/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown