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

Device Problem Material Integrity Problem (2978)

Patient Problem Fall (1848)

Event Date 05/02/2014

Event Type  malfunction  

Event Description

It was reported to hill-rom that while a patient was being lifted from bed to chair, a tear in the sling was noticed and the patient fell.

Manufacturer Narrative

A supplemental report will be sent when investigation has been performed and information requested has been received.

• Brand Name: LIKORALL
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedrevagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: joe fogel ; nedrevagen 100; lulea 975 9-2 ; SW 975 92 ; 20474700
• MDR Report Key: 4009396
• MDR Text Key: 16446049
• Report Number: 8030916-2014-00052
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/22/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2014
• Initial Date FDA Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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