MAUDE Adverse Event Report: LIKO AB UNO 102 EE; LIFT, PATIENT TRANSFER MOBILE

Model Number 2010004

Device Problems Thermal Decomposition of Device (1071); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/23/2018

Event Type  malfunction  

Manufacturer Narrative

The account technician found that the extension cable had a burned area and needed to be replaced.The service manual for mobile lifts (3en371001) inspection point 8 for battery, cables and charging states: check cables and connectors for damage or wear.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 extension cable to resolve the issue.

Event Description

Hill-rom received a report from the account stating that the charging cable was burned and produced sparks.The lift was located at (b)(6) in (b)(6) at the time of the incident.There was no patient or user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: UNO 102 EE
• Type of Device: LIFT, PATIENT TRANSFER MOBILE
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: erin padgett ; 1069 state route 46 east; batesville, IN 47006 ; 8129312791
• MDR Report Key: 7472019
• MDR Text Key: 107199278
• Report Number: 8030916-2018-00025
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Hospital Service Technician
• Type of Report: Initial
• Report Date: 04/23/2018

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: 2010004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/23/2018
• Initial Date FDA Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/13/2014
• 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