MAUDE Adverse Event Report: LIKO AB LIKORALL 240; NON-AC POWERED PATIENT LIFT

Model Number 3120613

Device Problem Detachment Of Device Component (1104)

Patient Problem Death (1802)

Event Date 05/04/2018

Event Type  Death  

Manufacturer Narrative

After the incident, a nurse at the account checked the slingbar and quick release hook and found no deficiency with either.The hill-rom technician inspected the lift and found no deficiency.The lift functioned as designed.The hill-rom technician found the police had cut off the liftstrap with q-link and confiscated the liftstrap and slingbar with quick release hook for their investigation.Hill-rom received pictures of the slingbar and quick release hook which confirms the nurse's statement that there were no deficiencies found with either.The liftstrap with q-link and slingbar have not been released by the police for hill-rom's evaluation.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 lift.The investigation is ongoing.However, if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating the slingbar released from the q-link when the patient was about to be lifted from the wheelchair to the bed.The patient fell to the floor, hit their head, and expired the next day.The lift was located at the account at the time of the incident.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: LIKORALL 240
• 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: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7553344
• MDR Text Key: 109562602
• Report Number: 8030916-2018-00026
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3120613
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/04/2018
• Initial Date FDA Received: 05/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/1990
• 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
• Patient Age: 90 YR
• Patient Weight: 83