MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VIKING XL; LIFT PATIENT NON AC POWERED

Model Number	2040043
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	Anxiety (2328)
Date of Event	10/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Viking l and xl mobile lifts are two versatile lift models intended mainly for use in health care, intensive care and rehabilitation.Viking l and xl mobile lifts are intended for heavier patients.Both models are excellent aids in daily transfers of adults and bariatrics, for instance, lifting to and from wheelchair, bed, toilet and floor.An inspection performed by a baxter technician noted that the lift had been used with a liko scale adapter, which broke during the transfer causing the patient fall.The liko scale adapter was replaced to resolve the issue.Feeling anxious and nervous can be characterized by uneasiness or worry that can be triggered by external factors such as a stressful event.Management includes but is not limited to, avoiding known triggers, relaxation techniques, and in more severe and persistent cases, medication.Anxiety is not a life-threatening condition.In this event, it was confirmed that 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, therefore, this event will be assessed as non-serious.The exact cause of the reported event is undetermined at this time, and a use error/misuse of the device cannot be excluded as the lift¿s scale and sling bar could have been unfavourably positioned and/or configured with an incorrect quick release hook, which could have caused the scale adapter breakage.If a similar event were to recur, it would be likely to cause or contribute to a serious injury or death.Any additional and relevant information received over the course of the investigation will be submitted in a final report.
Event or Problem Description
It was reported that during a patient transfer with a viking xl lift, the ¿lifting bar gave way (broken metal rod)¿ while the patient was suspended above his bed, causing the patient to fall in his bed.It was confirmed that the event did not result in patient injury, however, it was reported that the patient suffered from anxiety following the fall.
Additional Manufacturer Narrative
The baxter technician found the likoscale adapter kit was broken and needed to be replaced.Viking l and xl mobile lifts are two versatile lift models intended mainly for use in health care, intensive care and rehabilitation.Viking l and xl mobile lifts are intended for heavier patients.Both models are excellent aids in daily transfers of adults and bariatrics, for instance, lifting to and from wheel chair, bed, toilet and floor.A viking¿ mobile lift equipped with the viking¿ armrest accessory can be used for gait training.Horizontal lifting can also be performed in combination with a recommended liko¿ stretcher accessory.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this device.It is unknown if the facility performs preventative maintenance on their device.The technician replaced the likoscale adapter kit to resolve the reported event.Based on this information, no further action is required.

• Brand Name: VIKING XL
• 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: 23495055
• Report Number: 8030916-2025-00134
• Device Sequence Number: 18390718
• Product Code: FSA
• UDI-Device Identifier: 00887761981850
• UDI-Public: (01)00887761981850(11)240127
• 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): 03/09/2026

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
• Device Model Number: 2040043
• Device Catalogue Number: 2040043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2025
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 11/07/2025
• Supplement Report FDA Received Date: 03/09/2026
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 169 KG