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

Model Number	2000045
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Head Injury (1879)
Date of Event	12/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient fell from a golvo mobile lift and sustained an injury.During a patient transfer, the latch of the lift¿s sling bar came loose and the patient fell from a height of approximately one meter.The patient was transferred to the emergency department (ed).In the ed, the patient was found to have sustained a head wound requiring stitches and potential vertebral fractures.A device inspection performed by a baxter technician noted that the lift was working as designed.The lift strap was noted to be slightly twisted but operational, and one of the sling bar latches was missing on the sling bar and was replaced for the customer.The golvo 9000 instruction for use (ifu) states: "before lifting, always make sure that the lifting accessory is correctly attached to the lift; the lifting accessory is correctly and securely applied to the patient in order to prevent injuries; the sling¿s strap loops are correctly connected to the sling bar hooks when the sling straps are extended but before the patient is lifted from the underlying surface.¿.No further information was available at the time of this report.
Additional Manufacturer Narrative
E1: initial reporter address: (b)(6).H11: the device was evaluated onsite by a qualified technician.During functional testing the lift was found to be working properly.The strap is slightly twisted but is operational.A safety hook is missing on the bracket.The strap and safety hook were replaced.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.The investigation is currently ongoing, a final report will be submitted upon completion.

• 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 ; 2242702068
• MDR Report Key: 24023866
• Report Number: 8030916-2026-00003
• Device Sequence Number: 13057167
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: (01)00887761981737
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: NA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 2000045
• Device Catalogue Number: 2000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 01/09/2026
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown