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

Model Number 3130001

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/06/2016

Event Type  malfunction  

Manufacturer Narrative

When the technician investigated the product, he found the lift strap was worn and has been twisted at some point.According to 7en125103 rev.6 "multirall instruction guide", hill-rom states that the user shall always ensure before lifting that the lift strap is not twisted or worn and can move in and out of the lift freely.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.The technician found the drop was most likely due to the poor condition of the lift strap.The technician suggested replacement of the lift strap and to take the unit out of service.The hill-rom customer service representative provided the account with the part number for a new lift strap.The account will order and install a new lift strap to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the multirall overhead lift dropped down approximately 12 inches while raising a 220 pound patient.The lift was located at the account at the time of the allegation.There was no patient/user injury reported.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 975 9 2; SW 975 92
• Manufacturer Contact: marlene bjurman ; nedre vägen 100; luleå, norrbottens län 975 9-2 ; SW 975 92
• MDR Report Key: 5743136
• MDR Text Key: 48769093
• Report Number: 8030916-2016-00080
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 06/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 3130001
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/10/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/23/2013
• 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