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

Model Number 2020003

Device Problem Material Separation (1562)

Patient Problem No Patient Involvement (2645)

Event Date 11/12/2020

Event Type  malfunction  

Manufacturer Narrative

The account found that the red emergency stop button had fallen off the control box of the lift.Per the hillrom's periodic inspection for the liko¿ sit-to-stand lifts (3en371001 rev.5) instructs: press the emergency stop button.With the emergency stop pressed in, verify that the hand control buttons do not operate the lift.Turn the red emergency button in the direction of the arrows.Verify the button releases from the locked position into the raised, open position.No serial number was provided or obtained therefore a pm search could not be conducted.It is unknown if the facility performs preventative maintenance on their lift.The technician replaced the control box to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from the account stating that the red emergency stop button had fallen off.The lift was located at a patient's home.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: SABINA II EE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 10959513
• MDR Text Key: 240303041
• Report Number: 8030916-2020-00042
• 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: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2020003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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