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

Model Number 2040015

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/08/2015

Event Type  malfunction  

Event Description

Hill-rom rec'd a report from the accounting stating that the control box on the lift had a spark from where the charging cable is connected at the bottom of the control box.No smoke or flames could be seen.There was no pt/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The account found that the control box had no function.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 account replaced the control box to resolve the issue.Based on the info, no further action is required.

• Brand Name: VIKING M
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedrevagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: linnea hedlund ; nedrevagen 100; lulea 975 9-2 ; SW 975 92 ; 920474800
• MDR Report Key: 4862553
• MDR Text Key: 5849673
• Report Number: 8030916-2015-00085
• 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: 06/08/2015

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: 2040015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/08/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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