MAUDE Adverse Event Report: LIKO AB VIKING XL; MOBILE PATIENT LIFTING SYSTEM, BATTERY-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	07/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the hrc technician determined that the bolt had snapped off from the slingbar.Bolt and sling bar were replaced with new parts, and the lift is functioning as designed.The viking xl mobile lift is intended mainly for use in health care, intensive care and rehabilitation.It is intended for heavier patients and aids in the transfer of adults and bariatrics, for instance, lifting to and from wheelchair, bed, toilet, and floor.The device ifu notes to perform the following prior to performing a lift: ensure that the lifting accessory is properly attached to the lift, the accessory is not damaged, and the latches are intact; missing or damaged latches must always be replaced.Although there was no serious injury reported, if the reported malfunction were to recur during a patient transfer, it could lead to serious injury or death.Therefore, hillrom is reporting this event.
Event or Problem Description
The customer alleged the slingbar separated from the mast when in operation with the patient.The customer alleged the patient fell on the bed as a result of this alleged malfunction.There was no injury reported.This incident was captured under hillrom complaint ref (b)(4).

• Brand Name: VIKING XL
• Common Device Name: MOBILE PATIENT LIFTING SYSTEM, BATTERY-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] ; SW
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17575733
• Report Number: 8030916-2023-00060
• Device Sequence Number: 8877584
• Product Code: FSA
• UDI-Device Identifier: 00887761981850
• UDI-Public: 010088776198185011230602
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/18/2023

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: 07/20/2023
• Initial Report FDA Received Date: 08/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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