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

Device Problem Sparking (2595)

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

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

Hill-roms is sending this as a conservative report.A supplemental report will be filed when requested information has been received.

• Brand Name: VIKING M
• Type of Device: NON-AC POWERED PATIENT LIFT
• Manufacturer (Section D): LIKO AB; nedre vagen 100; lulea 975 92; SW 975 92
• Manufacturer Contact: joe fogel ; nedrevagen 100; lulea 975 9-2 ; SW 975 92 ; 20474700
• MDR Report Key: 3913099
• MDR Text Key: 4583803
• Report Number: 8030916-2014-00043
• 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: Health Professional
• 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: 05/28/2014
• Initial Date FDA Received: 06/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2008
• Is the Device Single Use?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1