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

Model Number 6001001

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/18/2015

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found that the arms were not bent, but that the unit was missing a front wheel.According to the service manual for the rollon (3en560401), the following shall be checked at periodic inspection: front wheels- roll the lift, unloaded, along the floor, checking to ensure that all castors roll and turn freely.- verify that castor fasteners are tight.7 rear wheels- lock brakes.Make sure the wheels do not turn and the castor housing does not swivel when the lift is pushed.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 hill-rom technician replaced the front wheel to resolve the issue.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating that the arms on the lift looked bent.The lift was located in the patient room at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

• Brand Name: ROLLON
• 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: linnea hedlund ; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 5290503
• MDR Text Key: 33900756
• Report Number: 8030916-2015-00154
• 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: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6001001
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/18/2015
• Initial Date FDA Received: 12/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2015
• 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