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

Catalog Number	2000045
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer contacted technical services to report that the golvo 9000 patient lift had an issue, the emergency stop on the control box was not working.This occurred before use.There was no patient/user injury, medical intervention, symptom, or adverse event reported.There were no other devices reported to be involved.The replacement part number was provided to the customer.This issue will be resolved with the installation of the new complete parts ordered by the customer.The device was not requested for service since troubleshooting and solution was provided via phone.
Additional Manufacturer Narrative
The golvo mobile lift in intended to be used for transferring patients between devices 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.The periodic inspection for mobile lifts and sit-to-stand lifts 3en371001, rev 5 states under 10 emergency stop: press the emergency stop button.With the emergency stop pressed in, verify that the hand control buttons do not operate the lift.Turn the red emergency button in the direction of the arrows.Verify the button releases from the locked position into the raised, open position.The golvo 9000 instructions for use recommends a periodic inspection of the lifts should be carried out at least once per year.It is unknown if they facility preforms preventative maintenance on their beds.The replacement part number was provided to the customer who will perform the repair to resolve the reported issue.Based on this information, no further actions are required.Although the reported event did not result in a serious injury, the report of an emergency button not functioning during patient transfer could contribute to a serious injury or death, if the malfunction were to recur.Therefore, baxter considers this a reportable malfunction.

• Brand Name: GOLVO 9000 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: 20457730
• Report Number: 8030916-2024-00081
• Device Sequence Number: 20774740
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: 00887761981737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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 Catalogue Number: 2000045
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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