MAUDE Adverse Event Report: LIKO AB MULTIRALL 200; NON-AC POWERED PATIENT LIFT

Model Number 3130001

Device Problem Detachment Of Device Component (1104)

Patient Problem Death (1802)

Event Date 05/27/2018

Event Type  Death  

Manufacturer Narrative

The hill-rom technician inspected the motor and the slingbar and found no deficiency with the parts.The technician tested the quick release function of the slingbar by attaching the slingbar to the motor and performing a load test.In the instruction guide for multirall 200 (b)(4), it is stated under operation: before lifting check that the quick-release hook is correctly attached to the q-link.This specific step in the instruction guide is highlighted with a warning triangle, indicating that the extra care and attention is required.The last performed preventative maintenance was done (b)(6) 2017.Hill-rom's investigation indicated there was no evidence of a malfunction.Hill-rom was unable to duplicate the alleged condition and the device performed as designed.

Event Description

Hill-rom received a report from the account stating the slingbar released from the motor when the patient was lifted from bed to the wheelchair.The patient fell as a result of the slingbar detaching and sustained bruises and cerebral concussion.The patient expired two days after the incident.The lift was located at the account at the time of the incident.This report was filed in our complaint handling system as (b)(4).

• Brand Name: MULTIRALL 200
• 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: 7633270
• MDR Text Key: 112145784
• Report Number: 8030916-2018-00033
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 05/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 3130001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/09/2013
• 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 Outcome(s): Death
• Patient Age: 75 YR