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

Model Number 3130001

Device Problems Device Slipped (1584); Detachment of Device or Device Component (2907)

Patient Problems Death (1802); Intracranial Hemorrhage (1891)

Event Date 12/16/2020

Event Type  Death  

Manufacturer Narrative

The hillrom technician evaluated the q-link i connection on the lift motor (multirall) and the carriage with hook (s65).There was no malfunction identified.The most probable root cause is the lift attachment point, the q-link, was not properly engaged in the s65 rail carriage hook.Per the instruction guide for the multirall 200 (7en125103 rev.6) there are pictorial descriptions of correct attachment of q-link to s65 rail hook.It is also stated: before lifting, always ensure that: the lift strap is not twisted or worn and can move in and out of the lift freely.The lifting accessories are not damaged.The lifting accessories are properly attached to the lift.The lifting accessories hang vertically and can move freely.Should a visual inspection have been performed before the lift, this incident is very unlikely to occur.A field safety corrective action (fsca), mod1267, was performed in 2017.Mod1267 included an advisory notice with reinforcement of the instructions for proper connection, including verification of proper attachment prior to use for the multirall 200 overhead lift to the s65 carriage.The healthcare facility, (b)(6), was included in this fsca.A new fsca, mod1322, which includes modification of all multirall 200 in the field, has been initiated in (b)(6) 2021.Mod1322 will replace the attachment point of the multirall 200 (q-link) with a new design, q-link ii.This will improve ease of use and mitigate potential risk to patient or caregiver.The fsca mod1322 will be performed in two phases: phase 1: a customer letter/field safety notice including a response from where the customer is asked to inspect the multirall installations at their facility and reply with the type of accessories that are used in the installations.Phase 2: hillrom will replace the q-link i on multirall lifts to q-link ii to improve ease of use and to mitigate potential risk to patient or caregiver.Based on this information, no additional action is required.

Event Description

Hillrom received a report from the account stating that the device fell from its hook.The caregiver was transferring the patient from a chair to the bed and thought that the lift was well hooked.The patient was lifted, chair removed, and while the resident was rotated towards the bed, the strap of the motor released from the hook.The patient fell head first to the ground and the lift fell on the patient's elbow and ribs.A physician examined the patient 10 minutes after the fall and the patient was conscious, but dazed.The patient was transported to the emergency room where a scan revealed a lump behind his head.The patient died of a traumatic brain injury and bleeding to the head the next morning on (b)(6) 2020.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: 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: 11198526
• MDR Text Key: 227752207
• Report Number: 8030916-2021-00004
• 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: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/07/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 90 YR
• Patient Weight: 80