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

Model Number	2000049
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Fall (1848)
Date of Event	04/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned and a baxter technician performed an inspection.The customer relayed to the technician that the sling used during the reported event was owned by the patient and of an unknown manufacturer.The reported condition was verified.It was confirmed that the sling bar tilted to one side, causing the detachment of the latch and the releasing of the sling strap; therefore, the cause of the event was due to excessive movement of the patient during the transfer, which made the system unbalanced.The lift¿s battery was replaced, although it appeared to be working well.Additionally, per the instructions for use (ifu), ¿ensure that the lifting accessories are suitable for the lift used.Exercise care and caution during use.As a caregiver, you are always responsible for the patient¿s safety.You must be aware of the patient¿s ability to make it through the lifting situation.If something is unclear, contact the manufacturer or supplier.¿ should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient fell from a golvo mobile lift during a transfer.During the patient transfer, the patient shifted, causing the sling bar to tilt, a latch to snap off, and the sling to slide off the hook.The patient was transferred to the emergency department (ed) for evaluation and was discharged with no injuries.A device inspection performed by a baxter technician noted that the lift was working as designed and the battery was replaced.The sling used was noted to be from an unknown manufacturer, and the event was likely due to excessive patient movement causing the system to become unbalanced.The golvo 9000 instruction for use (ifu) states: "ensure that the lifting accessories are suitable for the lift used.Exercise care and caution during use.As a caregiver, you are always responsible for the patient¿s safety.No further information was available at the time of this report.

• 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: 25167125
• Report Number: 8030916-2026-00059
• Device Sequence Number: 18772671
• Product Code: FSA
• UDI-Device Identifier: 00887761981751
• UDI-Public: (01)00887761981751(11)251128
• 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
• Report Date (Section B): 05/13/2026

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: Other
• Device Model Number: 2000049
• Device Catalogue Number: 2000049
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/28/2023
• 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