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

Model Number	2000015
Medical Device Problem Codes	Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information is available on the repair of the device at this time.The investigation is ongoing, however if any additional relevant information is identified following the completion of the investigation, the additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report that golvo 8008 had a lift sling disengaging from the loop at the top right corner.This occurred during patient use.There was no patient/user injury or medical intervention with this event.
Additional Manufacturer Narrative
It was reported that the service technician inspected the lift and found that the plastic belt guide was partially coming out with may indicate incorrect use of the lift.This belt guide had been preplaced in 2025.It was noted that the slingbar latches were missing.How the sling loop came loose remains unclear.The lift was recommended to get replaced due to being older than 10 years; technician resolved the issue by removing lift from customer site.The cause of the event was determined to be by incorrect use of the lift.Based on the inspection details provided by the distributor, it is reasonable to conclude that it was likely due to use error/misuse of the device (incorrect attachment of the sling to the sling bar, and/or improper servicing maintenance), which likely caused the loop of the sling to become loose from the bar/lift subsequently allowing the patient to slip out.If this type of event were to recur and a patient were to fall/drop from a significant distance and land on a hard surface, it would be likely to cause/contribute to a serious injury.

• 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: 24793562
• Report Number: 8030916-2026-00037
• Device Sequence Number: 9727232
• Product Code: FSA
• UDI-Device Identifier: 00887761981751
• UDI-Public: (01)00887761981751
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 06/02/2026

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: 2000015
• Device Catalogue Number: 2000015
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 06/02/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.
• Patient Sex: Female