MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GOLVO 9000 MOBILE LIFT; LIFT, PATIENT, NON-AC-POWERED

Model Number	2000045
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the technician found that one clip was missing and the other was damaged due to abuse during use.The technician replaced the slingbar latches to resolve.The model of the slingbar associated with this incident was not 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.The golvo 9000 instruction for use 7en140108 states: "check the sling bar latches are intact.Missing or damaged latches must always be replaced with new ones;" although there was no serious injury in this event, if the slingbar latch were to break or detach during a patient transfer, it would likely contribute to a serious injury or death.
Event or Problem Description
A company representative - service personnel contacted technical service to report that the golvo 9000 had an issue, missing clip off slingbar.This occurred during patient 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.

• Brand Name: GOLVO 9000 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 ; 2242702068
• MDR Report Key: 23720872
• Report Number: 8030916-2025-00143
• Device Sequence Number: 10464313
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: (01)00887761981737
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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
• Device Model Number: 2000045
• Device Catalogue Number: 2000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 12/04/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Unknown