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

Model Number 2020003

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 05/31/2019

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician evaluated the product and found the emergency switch was not working.In the instruction for periodic inspection guide for, 3en371001 rev.4, it is stated under 10 emergency stop: 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 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 lifts.Hillrom shipped a new control box to the account to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating the emergency switch was not working.The lift was located at the account at the time of the incident.There was no patient or user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: SABINA II EE
• 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: 8744233
• MDR Text Key: 149763201
• Report Number: 8030916-2019-00030
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2020003
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/31/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2018
• 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