MAUDE Adverse Event Report: LIKO AB VIKING XL; LIFT, PATIENT, NON-AC-POWERED

Model Number	2040043
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the technician found that the emergency stop switch had detached from the button.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.The viking¿ l / xl mobile lift instructions for use (7en137108) states the following under inspection and maintenance: for trouble-free use, certain details should be checked each day the lift is used: ¿ inspect the lift and check to make sure that there is no external damage.¿ check to make sure that the emergency lowering (both electrical and mechanical) works.A pm search was performed on this serial number resulting in no pm records found for this serial number.It is unknown if the facility performs their own maintenance.The technician reattached the switch to resolve the issue and the device was functioning as intended.Although there was no injury reported, if the emergency stop button became non functional during use it could lead to serious injury or death.Therefore baxter is reporting this malfunction.
Event or Problem Description
The customer alleged the emergency stop was not functioning correctly.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This incident was captured under complaint ref # (b)(4).

• Brand Name: VIKING XL
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20334101
• Report Number: 8030916-2024-00065
• Device Sequence Number: 8004208
• Product Code: FSA
• UDI-Device Identifier: 00887761981850
• UDI-Public: 010088776198185011220329
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/30/2024

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
• Device Model Number: 2040043
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/30/2024
• 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