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

Model Number	2040045
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The baxter technician replaced the battery and the power cord on the lift to resolve.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.An inoperative battery is likely to result in a temporary interruption or delay of therapy.If a low battery status is reached, the device will give a warning to charge the device.When the warning will initiate the lift will be able to complete one full lifting cycle with maximum load.After consideration for potential harms and worst-case scenarios, no serious adverse health consequence would occur from this issue.Although there was no adverse event reported, contact with exposed electrical wire can result in electrical injury.Therefore, if the reported malfunction of a damaged power cord with exposed wires were to recur, it could lead to serious injury or death.
Event or Problem Description
The baxter technician found the battery needed to be replaced and the power cord was damaged with exposed copper wires.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The customer did not communicate this event to another baxter department or authority.The device was requested for service/inspection by baxter.

• 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, 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: 22935977
• Report Number: 8030916-2025-00102
• Device Sequence Number: 9864967
• Product Code: FSA
• UDI-Device Identifier: 00887761981874
• UDI-Public: (01)00887761981874
• 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
• Report Date (Section B): 09/02/2025

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: 2040045
• Device Catalogue Number: 2040045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 09/02/2025
• 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