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

Model Number	2000045
Medical Device Problem Code	Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	Fall (1848)
Date of Event	11/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device was not returned; however, a baxter technician inspected the device during an on-site visit.The facilities director of nursing relayed to the technician that ¿the patients¿ family provided their personal sling for the liko lift and it did not have the correct fittings to be performing a lift¿.¿the family provided a third-party sling, that was purchased from amazon¿.The customer was unable to confirm the name of the third-party sling, and the sling was not accessible for testing as it was taken home by the patient¿s family.Therefore, the technician was not able to inspect the actual sling.The reported condition was verified.From the information relayed the sling ¿did not have the correct fittings;¿ therefore, the cause of the event was due to a user error.Additionally, per the instructions for use (ifu) ¿individual fitting of liko slings and other liko lifting accessories to meet the patient need is of the utmost importance for optimal performance and safety when using the lift.¿ a service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.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 and sustained an unspecified injury.Additionally, per the customer ¿the connection on the lift came loose and the patient fell about three feet to the floor¿.The patient sustained an unspecified injury and was transported to the hospital.The patient received unspecified treatment at the hospital and was discharged back to the facility later that evening.Multiple attempts to obtain additional details surrounding the event and injury were unsuccessful.Furthermore, a baxter technician spoke to the director of nursing of the facility and was informed ¿the patients¿ family provided their personal sling for the liko lift and it did not have the correct fittings to be performing a lift¿.¿the family provided a third-party sling, that was purchased from amazon¿.The customer was unable to confirm the name of the third-party sling, and the sling was not accessible for testing as it was taken home by the patient¿s family.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 ; 2242702068
• MDR Report Key: 23716279
• Report Number: 8030916-2025-00142
• Device Sequence Number: 15678865
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: (01)00887761981737(11)180619
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 2000045
• Device Catalogue Number: 2000045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/19/2018
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown