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

Model Number	2040044
Medical Device Problem Codes	Sparking (2595); Noise, Audible (3273)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Baxter received a report from a baxter technician to report the viking l sometimes sparks when the electrical connection between the battery and the socket is plugged in or disconnected.The bed was located at the account.This occurred during patient use.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.
Additional Manufacturer Narrative
No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Additional Manufacturer Narrative
The service technician inspected the lift and found that there was a crackling sound between the power cord and the control box.The technician confirmed that there were no sparks, flames, fire or explosion, just the crackling sound.This issue is determined to be caused by an electrical malfunction on the control box.The control box was replaced to resolve the alleged issue.The complaint information along with the arpc of burning smell was assessed for reportability based on fda requirements and in conjunction with the baxter device vigilance assessment document, and determined to be not reportable.A crackling sound from a device do not represent a hazardous situation to the user.The device is likely to be used in a medical environment (i.E.Physician's office, clinic, hospital) which is not an enclosed space and has approved ventilation systems.Therefore, if the device was to malfunction and result in smoke, the user and/or patient would likely move (or be moved) away from the smoking device and call for emergency assistance, and therefore the likelihood of severe injury or death is negligible.

• Brand Name: VIKING L
• 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: 23481820
• Report Number: 8030916-2025-00129
• Device Sequence Number: 13386724
• Product Code: FSA
• UDI-Device Identifier: 00887761981867
• UDI-Public: (01)00887761981867
• 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): 12/31/2025

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
• Operator of Device: Other
• Device Model Number: 2040044
• Device Catalogue Number: 2040044
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 12/31/2025
• 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