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

Model Number 2000049

Device Problem Defective Component (2292)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/21/2019

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the control box needed to be replaced.The emergency stop button is located on the control box.Per the periodic inspection for the golvo lift (3en371001 rev.4) section 10 instructs: press the emergency stop button.With the emergency stop button in, verify the lift does not operate with the hand control buttons.Turn the red emergency button in the direction of the arrows.Verify the button releases from the locked position into the raised, open position.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this lift in 2019.It is unknown if the facility performed any other preventative maintenance on this lift.The technician replaced the control box to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the emergency stop was not working.The lift was located 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 9000 LOWBASE
• 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: tony werner ; 1069 state route 46 east; batesville, IN 47006 ; 8129312359
• MDR Report Key: 8959724
• MDR Text Key: 156740533
• Report Number: 8030916-2019-00040
• 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: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2000049
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1