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

Model Number	2000049
Medical Device Problem Codes	Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Back pain (4895)
Date of Event	10/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H11: the device was evaluated on-site by a baxter qualified technician.During initial inspection, the left fork rack stop appeared broken due to the fork coming out of the base.The investigation is currently ongoing, a final report will be submitted upon completion.
Event or Problem Description
It was reported a golvo mobile lift failed wherein the patient¿s caregiver sustained an injury.During a patient transfer from a chair to the bed the golvo lift¿s (base) fork drive system (which increases the device's wheelbase width) failed, resulting in the lift¿s left fork coming off the base.While attempting to ¿restrain the patient,¿ (who eventually fell to the floor), the caregiver allegedly sustained a back injury presented as back pain.No medical intervention was reported; however, it was reported the caregiver took a ¿temporary six-day leave¿ from work.While the caregiver was provided extended time away from work, a serious temporary deterioration in the state of health cannot be ruled out at this time.No further information was provided.
Additional Manufacturer Narrative
The customer reported that the product is not available for service/inspection by baxter.Pictures provided in the complaint record showed that the gear rack was broken.It has been identified that the gear rack assembly was defective from wear and broke.When the caregiver continued to operate the lift, it resulted in the leg extending beyond its end stop.This led to the lift becoming unstable and tilting.No medical intervention was reported, including any prescribed rehabilitation treatment, and no further information has been provided.A replacement gear rack set was sent to the customer.Based on this information, no further actions are required at this time.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.A search of the baxter maintenance records showed baxter performed preventative maintenance on this device in jun 14, 2023.It is unknown if the facility performed any other preventative maintenance on this device.

• 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: 23486248
• Report Number: 8030916-2025-00133
• Device Sequence Number: 10330183
• Product Code: FSA
• UDI-Device Identifier: 00887761981751
• UDI-Public: (01)00887761981751
• 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,Followup
• Report Date (Section B): 06/29/2026

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: 2000049
• Device Catalogue Number: P2000009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2025
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 11/06/2025
• Supplement Report FDA Received Date: 06/29/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown