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

Model Number	2040034
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A other health care professional contacted technical service to report that the viking l patient lift power cord was fraying, stated copper wires showing.This occurred before 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.The device was requested for service/inspection by baxter.
Additional Manufacturer Narrative
The baxter technician replaced the control box to resolve the issue.Based on this information, no further actions are required at this time.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.Although there was no adverse event reported, frayed power cords with exposed copper wires can result in electrical injury.Therefore, baxter is reporting this device malfunction.

• 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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 20509478
• Report Number: 8030916-2024-00085
• Device Sequence Number: 9171383
• Product Code: FSA
• UDI-Device Identifier: 00887761981867
• UDI-Public: (01)00887761981867
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/22/2024

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: 2040034
• Device Catalogue Number: 2040034
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2024
• Initial Report FDA Received Date: 10/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2015
• 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