MAUDE Adverse Event Report: LIKO AB 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	12/16/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Upon inspection of the lift by a hillrom service technician, it was discovered that the two bolts that screw the lift mast to the base of the lift had been positioned in the wrong location, not securing the mast.The technician re-positioned the bolts in the correct location and the lift is now functioning as designed.The golvo mobile lift in intended to be used for transferring patients between devices (e.G., within the room); between bed/wheelchair, to/from the toilet, in bath and shower, floor lifting, horizontal lifting, and weighing patient.The golvo instructions for periodic inspection (3en371001, revision 4) states the following: "verify that both locking screws are tight in the base in the upper holes on the mast.Note: do not place any screws in the lower holes!" although the reported event did not result in a patient/caregiver injury, this type of malfunction could contribute to a serious injury or death if it were to recur.Therefore, hillrom considers this event reportable.
Event or Problem Description
The customer reported the lift¿s main body detached from the middle beam.There was no allegation of patient or caregiver injury or death reported from this alleged incident.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: GOLVO 9000
• 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: antonio acquafredda ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16156073
• Report Number: 8030916-2023-00003
• Device Sequence Number: 15344249
• Product Code: FSA
• UDI-Device Identifier: 00887761981737
• UDI-Public: 010088776198173711221012
• 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: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 01/13/2023

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
• 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: 12/16/2022
• Initial Report FDA Received Date: 01/13/2023
• 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