MAUDE Adverse Event Report: LIKO AB SABINA II EE; NON-AC POWERED PATIENT LIFT

Model Number 2020003

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/08/2015

Event Type  malfunction  

Event Description

Hill-rom received a report from the account stating that sparks came from the cable near the plug of the lift.The lift was not in use at the time.The lift was located in the pt room.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #(b)(4).

Manufacturer Narrative

The account found that sparks were coming from the plug that was damaged.A search of the hill-rom maintenance records did not show hill-rom performed preventative maintenance on this lift.It is unknown if the facility performs preventative maintenance on their lifts.The account sent the lift back to the distributor who conducted svc on the lift to resolve the issue.Based on this information, no further action is required.

• Brand Name: SABINA II EE
• 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: 4862554
• MDR Text Key: 5850635
• Report Number: 8030916-2015-00084
• 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: Other
• Type of Report: Initial
• Report Date: 06/02/2015

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: 2020003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 06/18/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2010
• 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