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

Model Number	P2040003
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the baxter technician found the emergency stop button 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 wheelchair, bed, toilet and floor.The baxter technician replaced the complete control box to resolve.Although there was no patient involvement reported, a report of a emergency function not working in an operative lift is likely to cause or contribute to a death or serious injury.
Event or Problem Description
During servicing by baxter, technical service identified that viking xlhad an issue, broken emergency stop button.This occurred during baxter servicing/testing.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.

• 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: 22852516
• Report Number: 8030916-2025-00100
• Device Sequence Number: 18236010
• Product Code: FSA
• UDI-Device Identifier: 00887761981850
• UDI-Public: (01)00887761981850
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/20/2025

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: P2040003
• Device Catalogue Number: P2040003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/29/2025
• Initial Report FDA Received Date: 08/20/2025
• 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