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

Model Number 3130001

Device Problems Detachment Of Device Component (1104); Misassembled (1398); Unintended Collision (1429)

Patient Problem Injury (2348)

Event Date 02/01/2017

Event Type  Injury  

Manufacturer Narrative

The hill-rom technician thoroughly inspected the lift and could not observe any malfunction.The lift functioned as designed.According to (b)(4) rev.02 "extension arm multirall", hill-rom states that the user shall make sure that the q-link is properly positioned into the carriage hook and that the lift strap is safely attached to the hook.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 lifts.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.An additional training session of the account's staff was proposed by hill-rom, but the account declined the training.An internal communication was circulated by the account regarding the importance of positioning the q-link correctly into the carriage hook.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the q-link on the lift strap was incorrectly mounted to the s65-carriage.Due to the misapplication, the q-link detached and the overhead lift landed on the patient´s stomach resulting in 3 broken vertebrae.The patient was hospitalized for one week and then returned to the account where he has to wear a girdle continuously for 2 months.The lift was located at caps at the time of the incident.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: MULTIRALL 200
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vägen 100; luleå, norrbottens län [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: marlene bjurman ; nedre vägen 100; luleå, norrbottens län [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 6391100
• MDR Text Key: 69487923
• Report Number: 8030916-2017-00007
• 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: Occupational Therapist
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 3130001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2017
• 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
• Patient Outcome(s): Hospitalization