MAUDE Adverse Event Report: LIKO AB LIKORALL 242 ES R2R,NATUR; NON-AC POWERED PATIENT LIFT

Model Number 3122007

Device Problems Device Inoperable (1663); Sparking (2595)

Patient Problem No Patient Involvement (2645)

Event Date 05/09/2016

Event Type  malfunction  

Manufacturer Narrative

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 account performs preventative maintenance on their lifts.The account requested hill-rom to cancel the work order since he had replaced the electronic card himself and the unit is now working properly.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the transfer function of the lift was inoperable and there was a spark in the transfer unit before it stopped working.The lift was located at the patient's home 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: LIKORALL 242 ES R2R,NATUR
• 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: 5670670
• MDR Text Key: 45920693
• Report Number: 8030916-2016-00067
• 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: 05/09/2016

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: Other
• Device Model Number: 3122007
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2016
• Initial Date FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2008
• 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