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

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Hill-rom if filing this as an initial report and are conducting a complaint investigation after receiving requested info.

• Brand Name: LIKORALL
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: katharina enstrom ; nedre vagen 100; lulea 975 9-2 ; SW 975 92 ; 20474700
• MDR Report Key: 3754129
• MDR Text Key: 4415166
• Report Number: 8030916-2014-00023
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Remedial Action: Replace
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/25/2014
• Initial Date FDA Received: 03/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2007
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1