MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION GOLVO 9000; LIFT PATIENT NON AC POWERED

Model Number	2000045
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection, the baxter technician found the slingbar safety latch was missing.The function of the latches on the universal slingbar is to prevent the sling harnesses from migrating out of the sling bar hook when the harness is slacked, for example, when no patient is being lifted in the sling.These latches make it easier for the caregiver to attach the sling loops to the sling bar hooks, preventing the sling loops from moving out of the hooks during preparation and before the patient is lifted.When used as intended, the latches are not subjected to forces and will not disconnect from the sling bar.When the sling loop is not properly resting in the hook, or is partially attached around the latch, the latches for the may detach early in the lifting process when subjected to minimal force.This design prevents a patient from being lifted to a height which could be potentially hazardous while the sling harness is improperly attached.In the instruction for use for universal sling bars (7en160185), the safety instruction section states: - before lifting, always make sure that 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.- for safety, load must be applied to all sling bar hooks on the sling bar during the lift! -incorrect attachment of sling to sling bar may cause severe injury to the patient.The baxter technician replaced the latch to resolve.Although there was no injury reported and the event was determined to be caused by use error, if the incident were to recur during a patient transfer, it could led to serious injury or death.
Event or Problem Description
A other health care professional contacted technical service to report that the slingbar latches snapped off.This occurred during patient use.It was reported that the patient fell from the hoist with no injury.

• Brand Name: GOLVO 9000
• 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: 22088108
• Report Number: 8030916-2025-00076
• Device Sequence Number: 6948128
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: (01)00887761981737
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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
• Report Date (Section B): 05/27/2025

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
• Device Model Number: 2000045
• Device Catalogue Number: 2000045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 05/27/2025
• 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
• Patient Sex: Unknown