MAUDE Adverse Event Report: LIKO AB LIKORALL 242 ES, NATURAL; NON-AC POWERED PATIETN LIFT

Model Number 3122005

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/29/2015

Event Type  malfunction  

Event Description

Hill-rom received a report form a hill-rom technician stating during a repair of an overhead lift, one of the connections sparked when first plugged into the charger.The lift was located at the account.There was no patient/user injury reported.This complaint 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 unknown if the facility performs preventative maintenance on their lifts.The technician replaced the battery, charger and charge station to resolve the issue.Based on this information, no further action is required.

• Brand Name: LIKORALL 242 ES, NATURAL
• Type of Device: NON-AC POWERED PATIETN LIFT
• Manufacturer (Section D): LIKO AB; nedrevagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: marlene bjurman ; nedrevagen 100; lulea 975 9-2 ; SW 975 92 ; 920474700
• MDR Report Key: 4862124
• MDR Text Key: 21773277
• Report Number: 8030916-2015-00080
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/01/2015

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: 3122005
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/01/2015
• Initial Date FDA Received: 06/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2010
• 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