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

Model Number 2020003

Device Problems Break (1069); Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/10/2015

Event Type  malfunction  

Manufacturer Narrative

The account found the screws that attached the slingbar were worn.In the service manual for sabina: make sure the hook assembly is installed according to these instructions.After installation, pull on the hooks (c) to make sure they do not come off.Make sure the latch (d) is mounted.Repairs and maintenance may only be performed by personnel authorized by hill-rom/liko and using original liko spare parts.Make sure the hooks are installed as the pictures shows.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 took the lift out of service to resolve the issue and they do not plan to repair the lift at this time.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the screws for fastening the hook of the lifting arm is damaged, causing the hook to be loose.The lift was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: SABINA II EE BASIC
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9 2; SW 975 92
• Manufacturer Contact: linnea hedlund ; nedre vagen 100; lulea, norrbottens lan [se-25] 975 9-2 ; SW 975 92
• MDR Report Key: 5310801
• MDR Text Key: 34616490
• Report Number: 8030916-2015-00169
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 2020003
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2006
• 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