MAUDE Adverse Event Report: LIKO AB LIKORALL 242 S, WHITE; NON-AC POWERED PATIENT LIFT

Model Number 3122010

Device Problems Device Emits Odor (1425); Sparking (2595); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating on a new installation, the hand control was in the charger and the up button was pressed on the hand control.This caused a spark in the motor and the down button on the hand control stopped working and they could smell an electrical burn smell from the e-card.The lift was located in a patient's home.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

A search of the hill-rom maintenance records did not show hill-rom performed any preventative maintenance on this lift.It is unk if the facility performs preventative maintenance on their lifts.The technician replaced the hand control and e-card to resolve the issue.Based on this info, no further action is required.

• Brand Name: LIKORALL 242 S, WHITE
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: marlene bjurman ; nedre vagen 100; lulea 975 9-2 ; SW 975 92 ; 20474700
• MDR Report Key: 4544466
• MDR Text Key: 5509038
• Report Number: 8030916-2015-00015
• 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
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 01/16/2015

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: Other
• Device Model Number: 3122010
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/16/2015
• Initial Date FDA Received: 02/12/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• 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