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 Codes	Hemorrhage/Blood Loss/Bleeding (1888); Intracranial Hemorrhage (1891); Laceration(s) (1946)
Date of Event	04/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional information: h3, h6 and h11.H11: no device malfunction was identified upon inspection.Reportedly, the caregiver was not following the instructions for use as the caregiver attached the sling loop to the sling bar hook in an incorrect way, the proper connection was not confirmed before lifting, the sling was detached from the sling bar, and the use of a non-approved combination.The instruction for use (ifu) states: "before lifting, always make sure that the lifting accessory is correctly applied to the lifting equipment; the lifting accessory is correctly and securely applied to the patient, so that no personal injury can occur; the sling¿s strap loops are correctly fastened to the sling bar hooks when the sling strap is extended, but before the patient is lifted from the underlying surface¿ a device inspection performed by a baxter technician noted that the lift was working as designed, no malfunction was identified.No further information was received regarding this event; therefore, based on the information that has been provided, this issue has been deemed a use error.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: the device was received for evaluation.During functional testing the device passed all necessary testing.The event history log review showed no evidence of the customer reported problem.The device was found to be performing per product specifications.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a patient fell while using the golvo mobile lift.During a patient transfer, the sling bar latches apparently fell off or broke prior to the patient fall.The patient was taken to the hospital for a potential head injury.Additionally, the patient sustained a 4 cm laceration to the left posterior scalp, which was repaired with sutures, a small amount of subarachnoid hemorrhage, and a left temporooccipital scalp hematoma.Per the instruction for use (ifu): "before lifting, always make sure that the lifting accessory is correctly applied to the lifting equipment; the lifting accessory is correctly and securely applied to the patient, so that no personal injury can occur; the sling¿s strap loops are correctly fastened to the sling bar hooks when the sling strap is extended, but before the patient is lifted from the underlying surface¿ a device inspection performed by a baxter technician noted that the lift was working as designed, no malfunction was identified.The customer did not allege specific malfunction.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 975 9 2; SW 975 92
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 21998628
• Report Number: 8030916-2025-00073
• Device Sequence Number: 13132490
• Product Code: FSA
• UDI-Device Identifier: 00887761981751
• UDI-Public: (01)00887761981751
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup
• Report Date (Section B): 07/31/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2000049
• Device Catalogue Number: P2000010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2025
• Supplement Date Received by Manufacturer: 07/04/2025
• Initial Report FDA Received Date: 05/09/2025
• Supplement Report FDA Received Date: 07/31/2025
• 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: NI.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown