MAUDE Adverse Event Report: LIKO AB SABINA II EE BASIC; NON-AC POWERED PATIENT LIFT

Model Number P2020003

Device Problems Component Missing (2306); No Fail-Safe Mechanism (2990)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

Hill-rom technical support informed the account that the emergency stop button was part of the control box and that needed to be replaced.Inspection protocol: liko¿ mobile lifts and liko¿ sit-to-stand lifts: press the emergency stop button.With the emergency stop pressed 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 did not show hill-rom performed any preventative maintenance on this lift.It is unknown if the facility performs preventative maintenance on their lifts.The account will replace 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 that a sabina ii lift had a missing emergency stop.The lift was located at the account at the time of the incident.There was no patient or caregiver injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: SABINA II EE BASIC
• 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: 8603218
• MDR Text Key: 145090008
• Report Number: 8030916-2019-00025
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P2020003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2012
• 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