MAUDE Adverse Event Report: LIKO AB GOLVO 9000 LOWBASE; LIFT, PATIENT, NON-AC-POWERED

Model Number	2000049
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	08/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The golvo mobile lift in intended to be used for transferring patients between devices, 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.Replacement parts were ordered to repair the lift.Periodic inspection 3en371001 rev.5, under section 3 states: castors wheels: roll the lift along the floor.Check to ensure that all wheels roll and turn freely.Make sure the wheels are fastened.Lock the brakes, make sure the wheels do not turn and the housing does not swivel when the lift is pushed.There should not be any play between the fork and the wheel nut.Although there was no patient injury associated with the reported event, the report of a wheel detaching if it occurred during a patient transfer could contribute to a serious injury or death.Therefore, hillrom considers this complaint a reportable malfunction.
Event or Problem Description
The customer alleged that a wheel was lost during use, the locking screws on the feet were loose and one was also missing under the foot spacer.There was no patient involvement.This report was filed in our complaint handling system as (b)(4).

• Brand Name: GOLVO 9000 LOWBASE
• Common Device Name: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 20198872
• Report Number: 8030916-2024-00059
• Device Sequence Number: 6674844
• Product Code: FSA
• UDI-Device Identifier: 00887761981751
• UDI-Public: 010088776198175111230614
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/12/2024

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
• Device Model Number: 2000049
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Initial Report FDA Received Date: 09/12/2024
• 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