MAUDE Adverse Event Report: LIKO AB GOLVO 8008; NON-AC POWERED PATIENT LIFT

Model Number 2000035

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 11/03/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the front right wheel needed to be replaced.Liko mobile lifts must be inspected at least once per year.According to the periodic inspection (3en371001- rev 5) for mobile lifts, the following shall be checked: 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.A search of the hillrom maintenance records showed no pm records for this serial number.It is unknown if the facility performed any preventative maintenance on this lift.The technician replaced the front right wheel, and tightened both front wheels to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the front right wheel of the lift fell off.The lift was located in the office at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #: (b)(4).

• Brand Name: GOLVO 8008
• 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: 10853095
• MDR Text Key: 218574638
• Report Number: 8030916-2020-00040
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2000035
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2016
• 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