MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VIKING M MOBILE LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number	2040045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	11/02/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient fell during a transfer with a viking m lift.A patient was being transferred from the bed to a geriatric chair with one caregiver when.Reportedly the sling loop was in place when the transfer began but came loose during the transfer and came out of the lift¿s sling bar.Allegedly, the patient fell to the floor headfirst, from a height of ¿approximately one meter.¿ the patient hit their head and sustained a wound on the back of their head.The nurse placed a pillow under the patient¿s head, and an ambulance was called.The patient was taken to the hospital, where the head wound was closed with three staples.A facility supervisor reviewed the incident with the caregiver present on the same day and concluded that the sling loop was likely not properly secured to the lift¿s sling bar.No further information was available at the time of this report.
Additional Manufacturer Narrative
H11: the device was evaluated onsite.During evaluation, the sling was found intact and both latches are ok.Per the facility the loop of the lifting sling could not have been properly secured on the lift arm hook.If it had been properly in place, the sling could not have come undone while tightening, unless it broke or was incorrectly positioned.The reported condition was verified.The cause of the event was due to a 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: VIKING M MOBILE 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: 23688865
• Report Number: 8030916-2025-00139
• Device Sequence Number: 6024004
• Product Code: FSA
• UDI-Device Identifier: 00887761981874
• UDI-Public: (01)00887761981874
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/01/2025

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?: No
• Operator of Device: Other
• Device Model Number: 2040045
• Device Catalogue Number: 2040045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2025
• Initial Report FDA Received Date: 12/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NI.
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Sex: Unknown