MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GOLVO 8000; LIFT, PATIENT, NON-AC-POWERED

Model Number	2000039
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/02/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information is available on the evaluation 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.
Event or Problem Description
On 02-jul-2025 the customer reported that a patient was injured while the golvo 8008 lowbase (product code 2000039, serial number (b)(6), lift was being used.The reporter initially stated they were unsure if the staff was responsible for the event or if the lift malfunctioned.During follow-up, the reporter stated that the event ¿was not a result of the equipment¿.There was no indication that the reported adverse event was serious in nature, and there was no report of required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.
Additional Manufacturer Narrative
On (b)(6) 2025 the customer reported that a patient was injured while the golvo 8008 lift was being used.The reporter initially stated they were unsure if the staff was responsible for the event or if the lift malfunctioned.During follow-up, the reporter stated that the event ¿was not a result of the equipment¿, however, despite multiple attempts to obtain additional information, no details of the reported patient injury was provided.The golvo mobile lift in intended to be used for transferring patients (adult or children) between devices (e.G., within the room), floor lifting, horizontal lifting, supporting patient limbs, ambulating patient, bathing patient, toileting patient, weighing patient and transferring patients from car.Intended for use in following environments: health care, intensive care, emergency ward, rehabilitation, habilitation.In this event, the customer did not provide the necessary information to determine the severity of the reported event.There was no indication that the reported adverse event was serious in nature, and there was no report of required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.Therefore, this event will be assessed as non-serious.Due to the sparsity of the information provided, the exact cause cannot be determined at this time, however, based on the customer report that the event ¿was not a result of the equipment¿, it is reasonable to conclude that the event was unlikely caused or contributable to the use of the device.The service technician inspected the lift and fund that the battery was unable to charge due to a failed control box.The control box did not charge the battery and needed to be replaced to resolve the alleged issue.The technician received information from the customer that the reported injury was due to user error.The only issue the technician found with the lift was the control box, which needed to be replaced due to no charging light.The technician replaced the battery to resolve the reported event.If any further, relevant information is received, the record will be reassessed accordingly.

• Brand Name: GOLVO 8000
• 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: 22675700
• Report Number: 8030916-2025-00094
• Device Sequence Number: 9472858
• Product Code: FSA
• UDI-Device Identifier: 00887761981751
• UDI-Public: (01)00887761981751
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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,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: 2000039
• Device Catalogue Number: 2000039
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 07/31/2025
• 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