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

Model Number	2000045
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device Fell (4014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.
Event or Problem Description
On 09-jan-2026, a other health care professional contacted technical service to report that golvo 9000 (product code 2000045, serial number (b)(6), had the mast separated from the frame while transferring a patient.This occurred during patient use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.
Additional Manufacturer Narrative
The technician confirmed that the screws in the upper holes on the mast came loose.Parts have been ordered to replace the base and the plate where the screws are attached.Based on the information that has been provided, it is likely to conclude that the mast has been incorrectly assembled on the base (installation/assembly error).The picture provided by the technician showed that the upper holes in the mast and base were not centered, which is an indication that the installation had not been carried out correctly.On golvo 9000 instructions for use (7en140108 rev.8) page 13 it is described how to assemble the lift and on page 15 it is described how to disassemble the lift.1.A) position the lift mast between the two black plastic plugs on the base cross member.B) then push the mast forwards as in the figure above so that it hooks onto the cross member.2.Install the two provided m6 screws into the upper holes on the lift mast.Do not install screws in the lower holes! a search of the baxter maintenance records showed baxter performed preventative maintenance on this device in mar 6, 2025.It is unknown if the facility performed any other preventative maintenance on this device.

• Brand Name: GOLVO MOBILE LIFT
• 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 ; 2242705355
• MDR Report Key: 24261816
• Report Number: 8030916-2026-00011
• Device Sequence Number: 9575028
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: (01)00887761981737
• 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): 04/16/2026

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: Health Professional
• Device Model Number: 2000045
• Device Catalogue Number: 2000045
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 03/20/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 04/16/2026
• 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