MAUDE Adverse Event Report: LIKO AB LIKORALL 250 S, NATURAL, IRC; NON-AC POWERED PATIENT LIFT

Model Number	3124050
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hrc service technician found that the lift was lowering even though the emergency stop button was pressed.Upon inspection wall charger adapter's led light is not lit up.According to the periodic inspection for liko overhead lifts (3en191001, rev.2), the emergency stop function should be checked at least once every year.In the document it is stated under section 5: check that the emergency stop (a) cord is secured properly and have no damage (if applicable).Activate the emergency stop button (b).Verify that it holds and locks in the activated position.With the emergency stop activated, check that the motor does not operate when the hand control buttons are pressed.Deactivate the emergency button.Verify that the button releases from the activated position into the deactivated 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.The technician reconnected the wall charger cable to resolve the issue.Based on this information, no further action is required.
Event or Problem Description
Hillrom received a report from a hillrom technician stating the lift was lowering even though the emergency stop button was pressed.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: LIKORALL 250 S, NATURAL, IRC
• Common Device Name: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• MDR Report Key: 12322475
• Report Number: 8030916-2021-00033
• Device Sequence Number: 11874125
• Product Code: FSA
• UDI-Device Identifier: 00887761979567
• UDI-Public: 010088776197956711190506
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 3124050
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 08/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1