MAUDE Adverse Event Report: LIKO AB LIKORALL 240; NON AC POWERED PATIENT LIFT

Model Number 3120613

Device Problem Device Slipped (1584)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/22/2015

Event Type  malfunction  

Manufacturer Narrative

Upon investigation, the hill-rom technician was unable to determine the root cause of the reported incident.The lift functioned as designed when inspected and he was unable to duplicate the incident.The most probable cause for the reported incident is that the lift strap was twisted when rolled into the lift, allowing for the sudden release when the strap untwisted.According instructions guide for likorall: before lifting, always ensure that the lift strap is not twisted or worn and can move in and out of the lift freely it is unknown if the facility performs preventative maintenance on their lifts.The hill-rom technicians inspected the lift and could not find any malfunctions.Based on this information, no further actions is required.

Event Description

Hill-rom received a report from the account stating that when they raised the patient, the liftstrap released approximately 15 cm length before coming to a stop.The lift was located at (b)(6).There was no patient/user injury reported.(b)(4).

• Brand Name: LIKORALL 240
• 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: 5340311
• MDR Text Key: 35285667
• Report Number: 8030916-2016-00002
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 3120613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/12/2004
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1