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

Model Number 2000045

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 10/21/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the mast attachment/locking screws were missing from the lift base.The golvo 9000 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! a search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this lift.It is unknown if the facility performs preventative maintenance on their lift.The technician replaced the mast attachment/locking screws to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom technical support received a report from the account stating the patient had just been lifted onto the bed.As the staff pulled the lift away from the bed, the lift arm (mast) separated from the base of the lift.There was no patient or user injury reported.The lift was located in 4 south at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: GOLVO 9000
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 10770655
• MDR Text Key: 232014830
• Report Number: 8030916-2020-00038
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2000045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1