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

Model Number	2040045
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
During inspection, the technician stated that on arrival there was no obvious fault with the hoist, but there have been previous occasions the outer tube can stop the mast from lowering with the motor.The technician replaced the outer tube.Investigation into what caused the reported malfunction is still on going.A final report will be submitted upon completion of the investigation.
Event or Problem Description
A customer contacted technical service to report that the viking m lift, had an issue, lift mast arm stopped and then dropped, hitting staff member on the head.This occurred during patient use.It was reported that there was a patient/user injury or medical intervention with this event.There were no other devices reported to be involved.
Additional Manufacturer Narrative
The service technician inspected the lift and found that the outer tube (item 20490030) was sticky.The outer tube was replaced and the lift was tested and functioning as designed.The technician was contacted for additional information about the event.The technician was not present when the event occurred, but he stated that the issue was probably caused by the spring (in the outer tube) being moved or twisted or potentially that the user was still supporting the arm on something.Based on this information, the likely cause to the issue is a mechanical malfunction.Viking m mobile lift is a general-purpose lift with the intended use in; health care, intensive care and rehabilitation.Viking m mobile lift is an excellent aid in daily transfers of both adults and children.With 3 various lifting height positions viking m mobile lift gives a flexibility for most lifting situations such as lifting to and from wheel chair, bed, toilet and floor.Although there was no injury associated with this event, if the reported incident were to recur it could result in serious injury or death.
Event or Problem Description
A customer contacted technical service to report that the viking m lift, had an issue, lift mast arm stopped and then dropped, hitting staff member on the head.This occurred during patient use.It was reported that there was a patient/user injury or medical intervention with this event.There were no other devices reported to be involved.

• Brand Name: VIKING M
• 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: 22993655
• Report Number: 8030916-2025-00105
• Device Sequence Number: 8997633
• Product Code: FSA
• UDI-Device Identifier: 00887761981874
• UDI-Public: (01)00887761981874
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 12/15/2025

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?: Yes
• Device Model Number: 2040045
• Device Catalogue Number: 2040045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 11/17/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 12/15/2025
• 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